Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
320
Countries
8
Sites
46
Idiopathic or Diabetic Gastroparesis
To evaluate the efficacy of a 12-week treatment with naronapride compared to placebo on disease signs and symptoms in participants with at least moderate idiopathic or diabetic gastroparesis.
Key facts
- Sponsor
- Dr. Falk Pharma GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 3 Jan 2023 → 5 Sep 2025
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510195-31-00
- EudraCT number
- 2021-002254-86
- ClinicalTrials.gov
- NCT05621811
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy, Safety
To evaluate the efficacy of a 12-week treatment with naronapride compared to placebo on disease signs and symptoms in participants with at least moderate idiopathic or diabetic gastroparesis.
Secondary objectives 2
- To determine the optimal dose-level of naronapride after completion of a 12-week treatment in participants with at least moderate idiopathic or diabetic gastroparesis.
- To evaluate safety and tolerability of naronapride compared to placebo in participants with at least moderate idiopathic or diabetic gastroparesis.
Conditions and MedDRA coding
Idiopathic or Diabetic Gastroparesis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Men and women between ≥18 and ≤75 years of age
- History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥ 3 months
- Evidence of delayed gastric emptying
- Average weekly total symptom score of ≥2.0
- Body Mass Index ≥16 and <35 kg/m2
- Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique
Exclusion criteria 6
- Participants without access to an internet-capable terminal and/or without an own e-mail address
- History of major gastrointestinal surgery
- Intrapyloric botulinum toxin injection within 12 months
- Active gastric stimulator implant
- Known secondary causes of gastroparesis
- Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
Secondary endpoints 2
- Change of the modified and composite average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
- Change of the average weekly symptom score for nausea/early satiety/postprandial fullness/upper abdominal pain/number of vomiting episodes/bloating from BSL to EOT/WD
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD9751847 · Product
- Active substance
- Naronapride Dihydrochloride Trihydrate
- Substance synonyms
- ATI-7505 dihydrochloride trihydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 2520 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- DR. FALK PHARMA G.M.B.H.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9752029 · Product
- Active substance
- Naronapride Dihydrochloride Trihydrate
- Substance synonyms
- ATI-7505 dihydrochloride trihydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 10080 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- DR. FALK PHARMA G.M.B.H.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9751854 · Product
- Active substance
- Naronapride Dihydrochloride Trihydrate
- Substance synonyms
- ATI-7505 dihydrochloride trihydrate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- DR. FALK PHARMA G.M.B.H.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dr. Falk Pharma GmbH
- Sponsor organisation
- Dr. Falk Pharma GmbH
- Address
- Leinenweberstrasse 5, Hochdorf Hochdorf
- City
- Freiburg Im Breisgau
- Postcode
- 79108
- Country
- Germany
Scientific contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- CTIS – Scientific Request
Public contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- Clinical Research and Development
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| QbD Flanders ORG-100046109
|
Antwerp, Belgium | On site monitoring, Code 12 |
| Leon Research S.L. ORG-100046049
|
Turin, Italy | On site monitoring, Code 12 |
| Proinnovera GmbH ORG-100010249
|
Muenster, Germany | On site monitoring, Code 11, Code 12, Code 13, Code 2, Code 5, Code 8, Code 9 |
| X-act Cologne Clinical Research GmbH ORG-100044002
|
Cologne, Germany | Code 10, Interactive response technologies (IRT), Data management, E-data capture |
| NextPharma GmbH ORG-100029766
|
Goettingen, Germany | Code 14 |
| Labor Dr. Spranger ORG-100045641
|
Ingolstadt, Germany | Laboratory analysis |
| OCT Clinical GmbH ORG-100044725
|
Hamburg, Germany | On site monitoring, Code 12 |
| Advanced Breath Diagnostics LLC DBA Cairn Diagnostics ORL-000008792
|
Brentwood, United States | Laboratory analysis |
Locations
8 EU/EEA countries · 46 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 2 | 1 |
| Belgium | Ended | 33 | 5 |
| France | Ended | 11 | 6 |
| Germany | Ended | 22 | 11 |
| Italy | Ended | 7 | 4 |
| Latvia | Ended | 6 | 2 |
| Netherlands | Ended | 4 | 2 |
| Poland | Ended | 117 | 15 |
| Rest of world
United Kingdom, Australia, United States, Switzerland
|
— | 118 | — |
Investigational sites
Kepler Universitaetsklinikum GmbH
Kepler Universitätsklinikum, Krankenhausstrasse 9, 4020, Linz
UZ Brussel
UZ Brussel, Laarbeeklaan 101, 1090, Jette
Antwerp University Hospital
University Hospital Antwerp, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Groeninge
Department of Gastroenerology, President Kennedylaan 4, 8500, Kortrijk
UZ Leuven
UZ Leuven Campus Gasthuisberg, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Cliniques Universitaires Saint-Luc, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHU De Bordeauxt
Hopital Haut Leveque, Hopital Haut Leveque, Avenue Magellan, Pessac
Assistance Publique Hopitaux De Paris
Hopital Louis Mourier Gastroenterology Unit, 178 Rue Des Renouillers, 92700, Colombes
Hospital Edouard Herriot
Hospices Civils de Lyon - Hopital Edouard Herriot, 5 Place D Arsonval, 69437, Lyon Cedex 03
CHRU De Nancy
CHRU de Nancy, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Lille
Service Maladies Appareil Digestif 1er etage Aile Est Hopital Claude Huriez, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire Rouen
CHU-Hopitaux de Rouen, 1 Rue De Germont, Bp 96031, Rouen Cedex
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH
Klinik am Bruderwald, Buger Strasse 80, Berg, Bamberg
Klinikum rechts der Isar der TU Muenchen AöR
Klinikum rechts der Isar der TU München, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Augsburg
Universitaetsklinikum Augsburg, Stenglinstrasse 2, Kriegshaber, Augsburg
Israelitisches Krankenhaus Hamburg
Viszeralmedizinisches Zentrum, Orchideenstieg 14, Alsterdorf, Hamburg
Universitaetsklinikum Brandenburg an der Havel GmbH
Med. Hochschule Brandenburg Theodor Fontane Campus Brandenburg/Städt. Klinikum Brandenburg, Hochstrasse 29, Altstadt, Brandenburg An Der Havel
SocraTec R&D Concepts in Drug Research and Development GmbH
SocraTec R&D GmbH, Mainzerhofplatz 14, Erfurt-Altstadt, Erfurt
Ruppiner Kliniken GmbH
Ruppiner Kliniken GmbH, Fehrbelliner Strasse 38, 16816, Neuruppin
LAKUMED KLINIKEN - Krankenhaus Vilsbiburg
Krankenhaus Vilsbiburg, Krankenhaus Vilsbiburg, Krankenhausstraße 2, Vilsbiburg
Sana Kliniken Berlin-Brandenburg GmbH
Sana Klinikum Lichtenberg, Fanningerstrasse 32, Lichtenberg, Berlin
Klinikum Region Hannover GmbH
KRH Klinikum Siloah, Stadionbruecke 4, Linden-Sued, Hanover
Eugastro GmbH
Gastroenterologie und Hepatologie am Johannisplatz, Johannisplatz 1, Zentrum Sudost, Leipzig
Azienda Ospedaliero-Universitaria Sant Andre
AOU Sant'Andre UOC Malattie dell'apparato digerente, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Ospedaliero Universitaria Pisana
Azienda Ospedaliero Universitaria Pisana UO Gastroenterologia, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera di Padova
Ambulatori di Gastroenterologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Universitaria Federico II Di Napoli
AOU Federico II UOSD Fisiopatologia Digestiva e Nutrizionale, Via Sergio Pansini 5, 80131, Naples
Digestive Diseases Centre Gastro SIA
Digestive Diseases Centre GASTRO, Gailezera Iela 1, 1079, Riga
Liepajas Regionala Slimnica SIA
Regional Hospital of Liepaja, Slimnicas Iela 25, 3414, Liepaja
Rijnstate Ziekenhuis Stichting
Rijnstate Ziekenhuis Stichting, Wagnerlaan 55, 6815 AD, Arnhem
Academisch Ziekenhuis Maastricht
Medical Center Maag/darm/lever, Clinical research unit, P Debyelaan 25, 6229 HX, Maastricht
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z o.o., Ul. Marii Konopnickiej 4, 82-200, Malbork
Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j.
Centrum Medyczne Clw-Med Aneta Cichomska i Joanna Łuka-Wendrowska, Spółka Jawna, Ul. Mieszka I 5, 86-300, Grudziadz
Ośrodek Badań Klinicznych Clinsante s.c. Ewa Galczak-Nowak Małgorzata Trzaska
Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Małgorzata Trzaska, Ul. Tytusa Chałubińskiego 6, 85-794, Bydgoszcz
Vita Longa Sp. z o.o.
VITA LONGA Sp. z o.o, Ul. Uniczowska 6, 40-748, Katowice
NZOZ Vita Diabetica Małgorzata Buraczyk
NZOZ Vita Diabetica Małgorzata Buraczyk, ul. sw. Rocha 12A lok. 5, 6 15-879, Bialystok
Ip Clinic Sp. z o.o.
IP Clinic Sp. z o.o, Ul. Gen. Lucjana Zeligowskiego 3/5, 90-752, Lodz
Centrum Medyczne LukaMed Joanna Łuka
Centrum Medyczne Lukamed, ul. Mickiewicza 39, 89-600, Chojnice
Allmedica Badania Kliniczne Sp. z o.o. sp.k.
Allmedica Badania Kliniczne Sp. z o.o. Sp.k., Ul. Kowaniec 2a, 34-400, Nowy Targ
Topsmed Sp. z o.o.
Topsmed Sp. z o. o., Ul. Albanska 12/1, 60-123, Poznan
Endoskopia Sp. z o.o.
Endoskopia sp. z o.o., Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Amicare Sp. z o.o. S.K.
AmiCare sp. z o.o. sp. k., Ul. Zgierska 249, 91-495, Lodz
Szpital Miejski Sw. Jana Pawla II W Elblagu
Szpital Miejski sw Jana Pawla II w Elblagu, Ul. Jana Amosa Komenskiego 35, 82-300, Elblag
Endopractica W Beker D Mielczarek P Mielczarek J Struzik s.c.
EndoPractica W. Beker, D. Mielczarek, P. Mielczarek, J. Struzik spółka cywilna, Błękitna Wstęga, Ul. Romana Horoszkiewicza 6, 45-001, Opole
Centermed Krakow Sp. z o.o.
CenterMed Krakow Sp. z o. o., Ul. Sw. Lazarza 14, 31-530, Cracow
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
NZOZ Twoje Zdrowie EL Sp. z o. o., Ul. Elizy Orzeszkowej 13, 82-300, Elblag
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-01-05 | 2025-05-16 | 2023-01-05 | 2025-05-15 | |
| Belgium | 2023-01-31 | 2025-05-28 | 2023-01-31 | 2025-05-15 | |
| France | 2024-04-04 | 2025-06-16 | 2024-04-04 | 2025-05-15 | |
| Germany | 2023-02-10 | 2025-08-26 | 2023-02-10 | 2025-05-15 | |
| Italy | 2025-01-30 | 2025-06-19 | 2025-01-30 | 2025-05-15 | |
| Latvia | 2023-10-24 | 2025-06-26 | 2023-10-24 | 2025-05-15 | |
| Netherlands | 2023-09-13 | 2025-05-16 | 2023-09-13 | 2025-05-15 | |
| Poland | 2023-01-03 | 2025-09-04 | 2023-01-03 | 2025-05-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 176 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_NAT-19_CTP_Redacted | 3 |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_AUT | NA |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_BEL-FRA | NA |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_BEL-NLD | 1.2 |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_FRA | 1.2 |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_GER | NA |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_ITA | 2 |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_LVA | NA |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_LVA-RUS | NA |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_NLD | 1.1 |
| Protocol (for publication) | D4_NAT-19_EQ-5D-5L_POL | NA |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_AUT_Redacted | 5 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_BEL-FRA_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_BEL-NLD_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_FRA_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_GER_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_ITA_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_LVA_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_LVA-RUS_Redacted | 4 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_NLD_Redacted | 3 |
| Protocol (for publication) | D5_NAT-19_ePro-MockUp_POL_Redacted | 7 |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_PlaceholderDoc | NA |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_AUT | 1 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_BEL | 1 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_FRA | 1 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_GER | 1 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_ITA | 1 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_LVA | 1 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_NLD | 3 |
| Recruitment arrangements (for publication) | K1_NAT-19_RecruitmInfoConsentProcedure_POL | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician_ | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Flyer_Physician_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Images Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Images Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Images Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Images Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Images Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Images Advertisement | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Landingpage_Physician_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_NLD_Website | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Website | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Website | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Website | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Website | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Website | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Website_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Native_Ads_Wording_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Pharmacy Journal_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Physician Journal_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design Template | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Design_ITA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Poster_Wording_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter_FRA | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Referral Letter_NLD | 2 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_ording_Social-Media_Patient | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Physician_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Social-Media_Patient | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Social-Media_Patient | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Social-Media_Patient | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Social-Media_Patient | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Social-Media_Patient_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SEA_Wording_Social-Media_Patient_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Social-Media_Wording-Physician_NLD | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_SocraTec_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording_FRA | 1 |
| Recruitment arrangements (for publication) | K2_NAT-19_RecrMat_Website_Wording_NLD | 1 |
| Subject information and informed consent form (for publication) | L1_ICF-Add-Blood-Samples | 3 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_FRA_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_NLD_Redacted | 8 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 9 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main-PrivacyForm | 3 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Main-RUS_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb | 4 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb | 3 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb | 2 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb | 3 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb | 4 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb | 3 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb_FRA | 4 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb_NLD | 4 |
| Subject information and informed consent form (for publication) | L1_NAT-19_ICF-Preg-Newb-RUS | 2 |
| Subject information and informed consent form (for publication) | L2_NAT-19_Append-ICF-Main_Site1903_redacted | N/A |
| Subject information and informed consent form (for publication) | L2_NAT-19_ICF-Preg-Newb | 2 |
| Synopsis of the protocol (for publication) | D2_NAT-19_Synopsis_FRA_redacted | 3 |
| Synopsis of the protocol (for publication) | D2_NAT-19_Synopsis_GER_redacted | 3 |
| Synopsis of the protocol (for publication) | D2_NAT-19_Synopsis_ITA_redacted | 3 |
| Synopsis of the protocol (for publication) | D2_NAT-19_Synopsis_NLD_redacted | 3 |
| Synopsis of the protocol (for publication) | D2_NAT-19_Synopsis_POL_redacted | 3 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | Germany | Acceptable 2024-07-31
|
2024-08-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-19 | Germany | Acceptable 2025-02-26
|
2025-02-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-07 | Acceptable 2025-02-26
|
2025-04-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-25 | Germany | Acceptable 2025-06-13
|
2025-06-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-25 | Germany | Acceptable | 2025-08-15 |