Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
60
Countries
1
Sites
1
post-operative swelling, pain and edema
To investigate whether Aescuven®, at a dose of 4 tablets per day (2 coated tablets b.i.d.), decreases post-operative swelling, edema, and pain after meniscus surgery
Key facts
- Sponsor
- Cesra Arzneimittel GmbH & Co. KG, Cesra Arzneimittel GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 31 May 2023 → 6 May 2024
- Decision date (initial)
- 2023-02-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Cesra Arzneimittel GmbH & Co. KG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To investigate whether Aescuven®, at a dose of 4 tablets per day (2 coated tablets b.i.d.), decreases post-operative swelling, edema, and pain after meniscus surgery
Secondary objectives 2
- To assess the impact of Aescuven® on swelling at different time points and on additional clinical parameters linked to meniscus surgery
- To assess tolerability and safety of Aescuven® in the therapy of swelling after meniscus surgery
Conditions and MedDRA coding
post-operative swelling, pain and edema
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10066415 | Post procedural swelling | 100000004863 |
| 20.1 | LLT | 10054711 | Postoperative pain | 10022117 |
| 21.1 | LLT | 10063647 | Post procedural edema | 10022117 |
Regulatory references
- Scientific advice from competent authorities
- Federal Institute For Drugs And Medical Devices
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Presence of the consent form personally signed and dated by the subject after the nature of the trial was fully explained by the Investigator and understood by the subject
- Age: 18 – 75 years at time of screening
- Diagnosis requiring meniscus arthroscopy, eligible and scheduled for unilateral knee surgery within max. 5 months after screening visit
- Willing and able to participate in the trial, to follow the instructions by the Investigator, to attend the visits and to agree to the procedures foreseen in the protocol.
Exclusion criteria 23
- Using compression stockings
- Complex Regional Pain Syndrome (CRPS: Morbus Sudeck)
- Physiological edema (myocardial insufficiency, renal insufficiency, liver cirrhosis, nutritional/protein deficiency edema/bulimia, thyroid deficiency/Grave’s disease, Cushing Syndrome)
- Other significant or insufficiently treated gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, as judged by the Investigator
- History of allergy/hypersensitivity to the trial medication, including intolerance to lactose
- Diagnosis of epilepsy
- BMI ≥ 30
- Alcoholism
- Under treatment with any drugs or food additives that might influence the results of the trial during the four weeks before start of the study
- Pregnant or breastfeeding
- Not using any accepted method of contraception
- Arthrosis of knee joint (Kellgren-Lawrence grade > grade II)
- Participation in another clinical trial within the 2 months preceding enrolment in this trial and/or during trial participation
- Member of site staff or trial team (Sponsor, CRO) directly involved in the trial conduct and their family members
- Muscle rupture/muscle hematoma
- History of vascular surgery or arteriosclerosis
- Vascular disease of the legs (e.g. phlebitis, thrombosis, varicosis)
- Lymphatic disease of the legs (lymphedema, erysipelas)
- Lipedema of the legs
- Acrodermatitis chronica atrophicans
- Chronic Obstructive Pulmonary Disease (COPD)
- Current infection with SARS-CoV-2
- Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Volume of the affected knee at visit 5, as determined by optoelectronic measurements
- Patient reported outcome measures at visit 5 (co-primary endpoint)
Secondary endpoints 10
- Volume of affected knee at visit 1, visit 2 (before surgery), visit 3 and visit 4, as determined by optoelectronic measurements
- Circumference of affected knee as determined by optoelectronic measurements at visit 1, visit 2 (before surgery), visits 3, 4, and 5
- Circumference of affected knee as determined by tape at visit 1, visit 2 (before surgery), visits 3, 4 and 5
- Range of motion (ROM) of the affected knee joint (Goniometry) at visit 1, visit 2 (before surgery), visits 3, 4 and 5
- Skin temperature at surgery site at visit 1, visit 2 (before surgery), visits 3, 4 and 5
- Volume of drained fluid after knee surgery at visit 3
- PROM at visits 1 - 4
- EQ-5D-5L Quality of Life questionnaire [15] at visit 1 and 5
- Efficacy of IMP as judged by the Investigator at final visit (end of study)
- Cumulative usage of analgetic drugs from visit 2 to final visit
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Aescuven 12,5 mg überzogene Tablette
PRD2322287 · Product
- Active substance
- Dry Extract of Horse Chestnut, Standardised (Der 5-7:1), Adjusted to 12.5 MG of Triterpene Glycosides Calculated as Protoaescigenin, Extraction Solvent: Ethanol 50% (M/M)
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 18 Day(s)
- Authorisation status
- Authorised
- ATC code
- C05CP01 — -
- Marketing authorisation
- 83286.00.00
- MA holder
- CESRA ARZNEIMITTEL GMBH AND CO. KG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The medicinal product will be individually labelled for the study while primary packaging remains intact. Apart from the individual labelling, no further modifications are planned.
Placebo 1
Tablets identical to "Test" in appearance and taste but containing no active ingredient
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
Cesra Arzneimittel GmbH & Co. KG
- Sponsor organisation
- Cesra Arzneimittel GmbH & Co. KG
- Address
- Braunmattstrasse 20, Haueneberstein Haueneberstein
- City
- Baden-Baden
- Postcode
- 76532
- Country
- Germany
Scientific contact point
- Organisation
- Cesra Arzneimittel GmbH & Co. KG
- Contact name
- MedWiss
Public contact point
- Organisation
- Cesra Arzneimittel GmbH & Co. KG
- Contact name
- MedWiss
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Arbeitskreis Klinische Pruefungen PD Dr. med. Seiler GmbH ORG-100041691
|
Freiburg Im Breisgau, Germany | On site monitoring, Code 10, Code 11, Code 2, Code 5, Data management, E-data capture |
| HWI Pharma Services GmbH ORG-100001868
|
Ruelzheim, Germany | Code 8 |
Cesra Arzneimittel GmbH & Co. KG
- Sponsor organisation
- Cesra Arzneimittel GmbH & Co. KG
- Address
- Braunmattstrasse 20, Haueneberstein Haueneberstein
- City
- Baden-Baden
- Postcode
- 76532
- Country
- Germany
Scientific contact point
- Organisation
- Cesra Arzneimittel GmbH & Co. KG
- Contact name
- MedWiss
Public contact point
- Organisation
- Cesra Arzneimittel GmbH & Co. KG
- Contact name
- MedWiss
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Arbeitskreis Klinische Pruefungen PD Dr. med. Seiler GmbH ORG-100041691
|
Freiburg Im Breisgau, Germany | On site monitoring, Code 10, Code 11, Code 2, Code 5, Data management, E-data capture |
| HWI Pharma Services GmbH ORG-100001868
|
Ruelzheim, Germany | Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
MVZ Gelenk-Klinik Dres. Schneider Ostermeier & Partner Arzte-Partnerschaft
Orthopedics, Alte Bundesstrasse 58, 79194, Gundelfingen
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 |
|---|---|---|---|---|---|
| Germany | 2023-05-31 | 2023-11-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results SUM-35048
|
2024-07-16T10:49:59 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results_lay | 2024-07-16T10:50:07 | Submitted | Laypersons Summary of Results |
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Summary of results_lay_DE | 1 |
| Laypersons summary of results (for publication) | Summary of results_lay_EN | 1 |
| Summary of results (for publication) | Summary of results | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-19 | Germany | Acceptable 2023-02-10
|
2023-02-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-11 | Germany | Acceptable | 2023-09-06 |