Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
80
Countries
1
Sites
5
patch adhesion trial with healthy subjects, therapeutical indication not studied
Key facts
- Sponsor
- Teikoku Seiyaku Co. Ltd., Teikoku Seiyaku Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 14 Sep 2023 → 13 Dec 2023
- Decision date (initial)
- 2023-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
patch adhesion trial with healthy subjects, therapeutical indication not studied
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10028338 | Muscle sprains | 10022117 |
| 20.0 | LLT | 10002550 | Ankle sprains and strains | 10022117 |
| 20.0 | LLT | 10028361 | Muscular pain | 10028395 |
| 20.1 | LLT | 10006502 | Bruise | 10022117 |
| 21.1 | LLT | 10028362 | Muscular pains | 10028395 |
| 20.0 | LLT | 10002549 | Ankle sprain | 10022117 |
| 20.0 | LLT | 10028337 | Muscle sprain | 10022117 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Teikoku Seiyaku Co. Ltd.
- Sponsor organisation
- Teikoku Seiyaku Co. Ltd.
- Address
- 567 Sanbonmatsu
- City
- Higashikagawa
- Postcode
- 769-2695
- Country
- Japan
Scientific contact point
- Organisation
- Teikoku Seiyaku Co. Ltd.
- Contact name
- Director, Regulatory Strategy & Intelligence
Public contact point
- Organisation
- Teikoku Seiyaku Co. Ltd.
- Contact name
- Director, Regulatory Strategy & Intelligence
Teikoku Seiyaku Co. Ltd.
- Sponsor organisation
- Teikoku Seiyaku Co. Ltd.
- Address
- 567 Sanbonmatsu
- City
- Higashikagawa
- Postcode
- 769-2695
- Country
- Japan
Scientific contact point
- Organisation
- Teikoku Seiyaku Co. Ltd.
- Contact name
- Director, Regulatory Strategy & Intelligence
Public contact point
- Organisation
- Teikoku Seiyaku Co. Ltd.
- Contact name
- Director, Regulatory Strategy & Intelligence
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 80 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Dr. med Jürgen Ulrich Schaale
na, Himmeroder Wall 7, 53359, Rheinbach
Dr. Helmut Pabst
na, Am Fuchsbogen 9, 82256, Fürstenfeldbruck
Dr. Eduard Ebert
na, Burgstr.26, 50321, Brühl
Kai Gastl
na, Römerstraße 49, 82205, Gilching
Prof. Dr. med. Hans-Georg Predel, Deutsche Sporthochschule Köln
Deutsche Sporthochschule Köln, Burgstr. 26, 50321, Brühl
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 | 2023-09-14 | 2023-12-13 | 2023-09-14 | 2023-10-29 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-23 | Germany | Acceptable 2023-06-19
|
2023-06-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-27 | Germany | Acceptable | 2023-08-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-11 | Germany | 2023-08-11 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-10-13 | Germany | 2023-10-13 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-10-16 | Germany | 2023-10-16 |