Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
558
Countries
2
Sites
46
Chronic back pain
Evaluation of efficacy of AP707 as add-on treatment in patients with chronic back pain
Key facts
- Sponsor
- Cannaxan GmbH, Apurano Pharmaceuticals GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 2 Nov 2023 → 10 Mar 2026
- Decision date (initial)
- 2023-04-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Evaluation of efficacy of AP707 as add-on treatment in patients with chronic back pain
Secondary objectives 1
- Evaluation of safety and tolerabilty of AP707
Conditions and MedDRA coding
Chronic back pain
Regulatory references
- Scientific advice from competent authorities
- Federal Institute For Drugs And Medical Devices, Federal Joint Committee
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Signed and dated informed consent form
- Patients with chronic back pain since at least 3 months
- Female and male patients (≥ 18 years)
- Patients with more than 1 year life expectancy
- Patients with optimized sCPT on study entry as defined in section 3.1.1 and section 3.1.3 of the study protocol
- Willingness of study patients of both sexes to use reliable contraception during study participation and for three months after taking the last study medication
- Good command of German language, in order to understand questionnaires in German
- Current moderate to severe pain with pain intensity > 5 on Numeric Rating Scale (NRS, 0 - 10) and thus an existing need for further pain therapy
- Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with 45 or less score points
- Completed painDETECT questionnaire with 20 or more score points
Exclusion criteria 15
- Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
- Known intolerance to cannabinoids or cannabis products
- Participation in another clinical trial within the last four weeks prior to inclusion
- Pregnant or nursing women (as excluded by pregnancy testing at visit 1 for women of childbearing potential)
- Other medical conditions that do not allow the trial subject to appraise the nature, scope, and potential consequences of the clinical trial
- Indications that the trial subject is unlikely to comply with the study protocol (e.g., unwillingness to cooperate)
- Known use of medicinal cannabis products within the last 8 weeks
- Active malignant tumor disease, tumor pain, or other dominant severe pain other than that of the study indication
- Known history of severe liver or kidney diseases
- Known history of severe cardiovascular disease
- Known history of or acute mental illness such as severe depression, psychosis, bipolar disorder, mania, anxiety, or obsessive-compulsive disorder
- Known history of addictive disease (e.g., alcohol, medication, drug addiction)
- Answered during Screening less than 12 times of 18 the pain intensity (NRS) inquiry
- Laboratory liver values: Alanine aminotransferase (ALT, GPT) > 3 x ULN (Upper Limit of Normal range), Aspartate aminotransferase (AST, GOT) > 3 x ULN, Alkaline phosphatase (AP) > 2.5 x ULN, Bilirubin > 1.5 x ULN
- Laboratory renal value: Serum creatinine > 1.5 ULN
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1) Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 14 (end of first treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
Secondary endpoints 16
- 2) Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 26 (end of second treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
- 3) Change in pain level on the Numeric Rating Scale (NRS, 0-10) between baseline and at treatment week 52 (end of third treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
- 4) Change in the pain score of the Neuropathic Pain Symptom Inventory (NPSI) questionnaire between baseline established in the last week before start of randomized treatment and at treatment week 14 (end of first treatment phase), at treatment week 26 (end of second treatment phase), and at treatment week 52 (end of third treatment phase) in comparison of study arm 1 (verum) and study arm 2 (placebo)
- 5) Change in pain level on the Numeric Rating Scale (0-10) between baseline and in treatment week 5, 11, 18, 22, 30, 34, 43, 47 in comparison of study arm 1 (verum) and study arm 2 (placebo)
- 6) Responder analysis for endpoints 1), 2), 3) and 4) for treatment week 14, 26 and 52: a) Proportion of patients who experienced > 30 % improvement in pain score (Numeric Rating Scale); b) Proportion of patients who experienced > 40 % improvement in pain score (Numeric Rating Scale); c) Proportion of patients who experienced > 50 % improvement in pain score (Numeric Rating Scale)
- 7) Change in sCPT (percentage of change in dosage and percentage of change in combination of analgesic measures) in both study arms from start to week 14
- 8) Change in pain-related impairment according to von Korff et al. from baseline established in the last week before start of randomized treatment to week 14, 26, and 52
- 9) Change in psychological distress using Depression Anxiety Stress Scales Short Form (DASS-21) questionnaire from baseline established in the last week before start of randomized treatment to week 14, 26, and 52
- 10) Change of Patient Global Impression of Change (PGIC) from start to week 14, 26, and 52
- 11) Change in quality of life using the Veterans RAND (VR-12) questionnaire from baseline established in the last week before start of randomized treatment to week 14, 26, and 52
- 12) Change in sleep quality using the Regensburg Insomnia Scale (RIS) from baseline established in the last week before start of randomized treatment to week 14, 26, and 52
- 13) Change in pain score of the Brief Pain Inventory - Short Form (BPI-SF) questionnaire from baseline established in the last week before start of randomized treatment to week 14, 26, and 52
- 14) Area under NRS-curve until treatment week 5, 11, 14, 18, 22, 26, 30, 34, 39, 43, 47, 52
- 15) Change in VR-12 components (physical component summary PCS, mental component summary MCS) from baseline established in the last week before start of randomized treatment to week 14, 26, and 52
- 16) Number of patients with rescue medication over the course of the clinical trial and within periods: until treatment week ≤5, ≤11, ≤14, ≤18, ≤22, ≤26, ≤30, ≤34, ≤43, ≤47, ≤52
- 17) Number and severity of adverse events (AE)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10071357 · Product
- Active substance
- Adezunap
- Pharmaceutical form
- OROMUCOSAL SPRAY, SUSPENSION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 20.83 ml millilitre(s)
- Max total dose
- 923.32 ml millilitre(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- N02BG10 — -
- MA holder
- CANNAXAN GMBH
- 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
Auxiliary 16
SCP996019 · ATC
- Active substance
- Aceclofenac
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 9999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AB16 — ACECLOFENAC
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP30317054 · ATC
- Active substance
- Dexketoprofen
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AE17 — DEXKETOPROFEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP7404627 · ATC
- Active substance
- Dexibuprofen
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AE14 — DEXIBUPROFEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP813617 · ATC
- Active substance
- Amitriptyline
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 9999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N06AA09 — AMITRIPTYLINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP787534 · ATC
- Active substance
- Acemetacin
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AB11 — ACEMETACIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP191862 · ATC
- Active substance
- Naproxen
- Substance synonyms
- LT-NS001
- Route of administration
- ORAL
- Max daily dose
- 1.25 g gram(s)
- Max total dose
- 999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AE02 — NAPROXEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP136109 · ATC
- Active substance
- Metamizole
- Substance synonyms
- METAMIZOL
- Route of administration
- OTHER USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 9999999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BB02 — METAMIZOLE SODIUM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2017420 · ATC
- Active substance
- Ketoprofen
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 9999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AE03 — KETOPROFEN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP140834 · ATC
- Active substance
- Tiaprofenic Acid
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AE11 — TIAPROFENIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4316924 · ATC
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Route of administration
- ORAL
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 999999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BA01 — ACETYLSALICYLIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP249643 · ATC
- Active substance
- Celecoxib
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AH01 — CELECOXIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6130832 · ATC
- Active substance
- Diclofenac
- Substance synonyms
- DICLOFENAC FREE ACID
- Route of administration
- UNKNOWN USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AB05 — DICLOFENAC
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- OTHER USE
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP199291 · ATC
- Active substance
- Imipramine Hydrochloride
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 9999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N06AA02 — IMIPRAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6158571 · ATC
- Active substance
- Phenazone
- Substance synonyms
- ANTIPIRINE, ANTIPYRINE, ANTIPYRIN
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999999999 Kg kilogram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02BB01 — PHENAZONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
N02A · Product
- Pharmaceutical form
- -
- Route of administration
- OTHER USE
- Max daily dose
- 99999999999999999999999999999999999999999999999999999999999999999999999 g gram(s)
- Max total dose
- 99999999999999999999999999999999999999999999999999999999999999999999999 g gram(s)
- Max treatment duration
- 9999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02A — OPIOIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cannaxan GmbH
- Sponsor organisation
- Cannaxan GmbH
- Address
- Birkerfeld 12, Lochham Lochham
- City
- Warngau
- Postcode
- 83627
- Country
- Germany
Scientific contact point
- Organisation
- Cannaxan GmbH
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Cannaxan GmbH
- Contact name
- Medical Affairs
Apurano Pharmaceuticals GmbH
- Sponsor organisation
- Apurano Pharmaceuticals GmbH
- Address
- Birkerfeld 12, Lochham Lochham
- City
- Warngau
- Postcode
- 83627
- Country
- Germany
Scientific contact point
- Organisation
- Apurano Pharmaceuticals GmbH
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Apurano Pharmaceuticals GmbH
- Contact name
- Medical Affairs
Locations
2 EU/EEA countries · 46 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 76 | 8 |
| Germany | Ended | 482 | 38 |
| Rest of world | — | 0 | — |
Investigational sites
Klinikum Klagenfurt Am Woerthersee
Department of Anesthesiology and Intensive Care Medicine, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Noe LGA Gesundheit Region Mitte GmbH
Clinical Department of Neurology, Alter Ziegelweg 10, 3430, Tulln An Der Donau
Schmerzkompetenzzentrum
Pain Competence Center, Badner Straße 8, 2540, Bad Vöslau
Medical University Of Vienna
Dept. of Anaesthesia, Intensive Care Medicine and Pain Medicine, Division of Special Anaesthesia, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinik Oberwart
Department of Neurology, Dornburggasse 80, 7400, Oberwart
Oberoesterreichische Gesundheitsholding GmbH
Neurology, Sierninger Straße 170, 4400, Steyr
Klinikum Wels-Grieskirchen GmbH
Department for Neurology, Grieskirchner Straße 42, 4600, Wels
Kepler Universitaetsklinikum GmbH
Clinic for Neurology 2, Krankenhausstrasse 7a, 4020, Linz
Ruhr University
St. Josef Hospital, Clinic for Neurology, Gudrunstrasse 56, Grumme, Bochum
BG Klinikum Hamburg gGmbH
Pain Medicine, Bergedorfer Strasse 10, Lohbruegge, Hamburg
University of Leipzig
Clinic and Polyclinic for Anesthesiology and Intensive Care Therapy, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Schmerztherapiezentrum Brau Michel
Center for Pain Therapy, Julius-Heywinkel-Weg 1, Westerberg, Osnabrück
Algesiologikum MVZ GmbH
Algesiologikum MVZ, Hessstrasse 22, Maxvorstadt, Munich
Westmecklenburg Klinikum Helene von Buelow GmbH
Center for Pain and Back Therapy, Parkstraße 12, 19230, Hagenow
BG Klinik Tübingen
Pain Medicine, Schnarrenbergstrasse 95, 72076, Tübingen
Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum
Clinic for Anesthesiology, Surgical Intensive Care, Pain and Palliative Medicine, Hoelkeskampring 40, Herne-Sued, Herne
Praxis Fur Neurologie
Practice for Neurology, Haus 1, Lindenallee 7, Hoppegarten
Klinikum rechts der Isar der TU Muenchen AöR
Clinic and Polyclinic for Neurology, Ismaninger Straße 22, Au-Haidhausen, Munich
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH
Neurology, Buerkle De La Camp-Platz 1, Wiemelhausen, Bochum
BG Klinikum Duisburg gGmbH
Pain Medicine, Grossenbaumer Allee 250, Buchholz, Duisburg
Universitaetsklinikum Essen AöR
Clinic for Neurology, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Giessen und Marburg GmbH
Clinic for Anesthesia and Intensive Therapy, Baldingerstrasse 1, 35043, Marburg
Praxisklinik Dr. Ibrahim & Kollegen
Pain center and practice clinic, Willy-Brandt-Platz 5, 81829, München
Staedtisches Klinikum Karlsruhe gGmbH
Center for Pain Therapy, Moltkestraße 90, Weststadt, Karlsruhe
Saarland University Hospital
Center for Cross-age Palliative Care and Pediatric Pain Therapy, Gebaeude 52 57, Kirrberger Strasse 100, Homburg
Schmerztherapiezentrum Villingen-Schwenningen
Center for Pain Therapy, Albert-Schweitzer-Str. 6, 78052, Villingen-Schwenningen
Universitaetsklinikum Tuebingen AöR
Clinic for Anesthesiology and Intensive Care Medicine, Hoppe-Seyler-Strasse 3, Nordstadt, Tuebingen
Medicross MVZ GmbH
MediCross MVZ, Bahnhofplatz 4, 74172, Neckarsulm
Schwerpunktpraxis Fuer Schmerztherapie Berufsausübungsgemeinschaft GbR
Specialized Practice for Pain Therapy, Bahnhofstraße 13, Mitte, Ulm
Schmerzzentrum Inn-Salzach
Center for Pain Therapy, Wackerstrasse 7, 84489, Burghausen
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Clinic for Anesthesiology, Intensive Care and Pain Medicine, Warener Strasse 7, Biesdorf, Berlin
Zentrum für Schmerz- und Palliativmedizin Schwerte
Center for Pain and Palliative Medicine, Große Marktstr. 5, 58239, Schwerte
University Hospital Augsburg
Clinic for Anesthesiology and Surgical Intensive Care Medicine, Stenglinstrasse 2, Kriegshaber, Augsburg
Gemeinschaftspraxis Michael Jokiel und Andreas Lütgen
Joint Practice, Facharztzentrum I am Krankenhaus, Propst-Sievert-Weg 8, Borken
Ueberoertliche Berufsausuebungsgemeinschaft Schmerz Und Palliativzentrum Rhein Main GbR
Center for Pain Therapy and Palliative Care, Broennerstrasse 15, Innenstadt, Frankfurt Am Main
Klinikum Dortmund gGmbH
Clinic for Neurology, Beurhausstrasse 40, Mitte, Dortmund
University Medical Centre Schleswig-Holstein
Clinic for Anesthesiology and Surgical Intensive Care Medicine, Schwanenweg 21, Arnold-Heller-Straße 3, Brunswik, Kiel
Charite Universitatsmedizin Berlin KöR
Clinic for Anesthesiology with Focus on Surgical Intensive Care Medicine, Hindenburgdamm 30, Lichterfelde, Berlin
Christliches Klinikum Unna gGmbH
Clinic for Anesthesiology, Intensive Care, Emergency, Pain and Palliative Medicine, Obere Husemannstrasse 2, 59423, Unna
Hausarztzentrum Butendorf
Medical Practice, Horster Strasse 137, Butendorf, Gladbeck
Schmerzzentrum Bocholt
Center for Pain Therapy, Kreuzstrasse 15, Stadt, Bocholt
Katholisches Klinikum Bochum gGmbH
Center for Sexual Health and Medicine, Bleichstrasse 15, Innenstadt, Bochum
Universitatsklinikum Würzburg AöR
Orthopedic Department of the University Hospital Würzburg, Brettreichstraße 11, 97074, Würzburg
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR
Clinic for Anesthesiology, Langenbeckstraße 1, 55131, Mainz
Schmerzzentrum Geldern
Praxis, An der Insel 15, 47608, Geldern
Universitätsklinikum Frankfurt
Clinic for Anesthesiology, Theodor-Stern-Kai 7, 60590, Frankfurt
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 | 2023-12-04 | 2024-03-20 | 2025-01-28 | ||
| Germany | 2023-11-02 | 2023-11-13 | 2025-01-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-70148
- Halt date
- 2025-01-28
- Member states concerned
- Germany
- Publication date
- 2025-02-10
- Reason
- Study management related
- Explanation
- The recruitment for the clinical trial was halted due to a request of the competent authority based on findings in an inspection according to that personal data of the participants are accessible to the sponsor. Additionally, concerns about the current level of monitoring, especially the low level of on-site monitoring, and its documentation being not adequate to ensure that the rights, safety and well-being of participants are protected. A modification of inadequate procedures is requested to meet all responsibilities of the sponsors and the sites.
- Follow-up measures
- First measures to correct the accessibility of personal data have already been implemented on 11.11.2024. The level of on-site monitoring activities has been increased steadily and will continue based on an updated monitoring plan. Additionally, a detailed CAPA will be initiated based on inspection findings and extended measures will be implemented.
Due to the implemented changes, enrolled participants are already provided with extensive measures, both protecting their personal data and ensuring their rights, safety and well-being. Their required procedures as well as the supply with the investigational product required in the clinical trial are ensured together with an improved oversight through the sponsor. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-70146
- Halt date
- 2025-01-28
- Member states concerned
- Austria
- Publication date
- 2025-02-10
- Reason
- Study management related
- Explanation
- The recruitment for the clinical trial was halted due to a request of the competent authority based on findings in an inspection according to that personal data of the participants are accessible to the sponsor. Additionally, concerns about the current level of monitoring, especially the low level of on-site monitoring, and its documentation being not adequate to ensure that the rights, safety and well-being of participants are protected. A modification of inadequate procedures is requested to meet all responsibilities of the sponsors and the sites.
- Follow-up measures
- First measures to correct the accessibility of personal data have already been implemented on 11.11.2024. The level of on-site monitoring activities has been increased steadily and will continue based on an updated monitoring plan. Additionally, a detailed CAPA will be initiated based on inspection findings and extended measures will be implemented.
Due to the implemented changes, enrolled participants are already provided with extensive measures, both protecting their personal data and ensuring their rights, safety and well-being. Their required procedures as well as the supply with the investigational product required in the clinical trial are ensured together with an improved oversight through the sponsor. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-DE-0001
- Member state
- Germany
- Publication date
- 2025-02-07
- Type
- 4
- Reason
- 4
- Immediate action required
- No
- Justification
- A clinical trial may be conducted only where the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored (Regulation (EU) 536/2014, Art. 28 (1) (a)). The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is conducted in accordance with the protocol and with the principles of good clinical practice (Regulation (EU) 536/2014, Art. 47). In view of the latest inspection findings, there are justified grounds for considering that these requirements are not met. The member states concerned intend to suspend the clinical trial (Regulation (EU) 536/2014, art. 77 (1) (b)). The sponsor is requested to deliver its opinion on this (Regulation (EU) 536/2014, art. 77 (2)).
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 10.03.0006 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Facebook Fotos | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Facebook Option 1 | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Facebook Option 2 | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Landingpage Option 1 | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Landingpage Option 2 | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material patient flyer | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material SchmerzLOS | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material social media | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults | 5.00.0003 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF participant pregnancy | 1.02.0005 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF participant_s partner pregnancy | 2.01.0004 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material badge | 3 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material brochure | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material quickstart spray counting device | 2 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-28 | Germany | Acceptable 2023-04-03
|
2023-04-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-12 | Acceptable | 2023-08-03 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-05-12 | Germany | Acceptable | 2023-06-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-08-21 | Germany | Acceptable 2023-10-19
|
2023-10-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-9 | 2023-12-08 | Germany | Acceptable 2024-02-09
|
2024-02-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-18 | 2024-11-13 | Germany | Acceptable | 2024-11-22 |