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
Characterization of adhesion 5 min prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
Key facts
- Sponsor
- 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
- Funding sources
- Teikoku Seiyaku Co Ltd.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Characterization of adhesion 5 min prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
Secondary objectives 4
- Characterization of adhesion by visual estimation of subjects
- Characterization of adhesion by the adhesion assessment by site staff with EFTS marked by subjects
- Comparison of the adhesion assessments between subjects and study staff
- Characterization of local tolerability during treatment
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 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Period I One period of three subsequent assessment days of 24 h each. On each day, 2 patches will be applied over 24 h., i.e. overall application of 6 patches.
|
Randomised Controlled | None | Group 1: Day1: Lower arm, Day2: Lower thigh, Day3: Ankle Group 2: Day1: Upper arm, Day2: Upper thigh, Day3: Lower leg |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, Federal Institute For Drugs And Medical Devices
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-003918-14 | Characterisation of relative bioavailability of a newly developed S-flurbiprofen containing patch formulation in comparison with a marketed oral flurbiprofen containing tablet formulation – a multiple dose, randomised, 2-period crossover-trial | |
| 2020-005165-14 | Randomized, controlled, double-blind, multi-center trial to evaluate the , Randomisierte, kontrollierte, doppelblinde, multizentrische Studie zur Bewertung der Wirksamkeit und Sicherheit eines Esflurbiprofen-Hydrogelpflasters im Vergleich zu Placebo bei der lokalen symptomatischen und kurzfristigen Behandlung von Schmerzen bei akuten Zerrungen, Verstauchungen oder Prellungen der Extremitäten nach einem stumpfen Trauma , z.B Sportverletzungen. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. age: 18 to 64 years
- 2. good state of health
- 3. non-smoker or ex-smoker for at least 3 months
- 4. written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial
Exclusion criteria 18
- 1. any injury of body which may induce the restriction of body movement
- 2. excessively hairy skin at application site
- 3. current skin disorder or shaving hair at application site
- 4. history of excessive sweating/hyperhidrosis inclusive of application site
- 5. participation in a clinical study within 30 days before inclusion in the study or concomitantly
- 6. drug or alcohol abuse in the opinion of the investigator
- 7. pregnant and lactating women
- 8. women of child-bearing potential who do not agree to apply highly effective contraceptive methods (as defined in the clinical trial protocol)
- 9. known hypersensitivity to Esflurbiprofen R-flurbiprofen or one of the excipients of the EFTS
- 10. existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 11. existing hepatic and/or renal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 12. known liver or kidney insufficiency
- 13. existing gastrointestinal diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient
- 14. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
- 15. systolic blood pressure < 90 or > 139 mmHg
- 16. diastolic blood pressure < 60 or > 89 mmHg
- 17. pulse rate < 50 bpm or > 90 bpm
- 18. subjects who use any impermissible medication (defined in the study protocol)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Assessment of EFTS adhesion 5 min prior to removal by the adhesion assessment by site staff with EFTS marked by site staff
Secondary endpoints 2
- Assessment of EFTS adhesion before bedtime (-1h), after waking up (+1h), and 5 min prior to removal by the visual adhesion assessment by subject
- Assessment of EFTS adhesion before bedtime (-1h), after waking up (+1h), and 5 min prior to removal by site staff with EFTS marked by subject
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Esflurbiprofen hydrogel patch 165 mg (EFHP)
PRD7952240 · Product
- Active substance
- Esflurbiprofen
- Pharmaceutical form
- TRANSDERMAL PATCH
- Route of administration
- TOPICAL APPLICATION
- Max daily dose
- 330 mg milligram(s)
- Max total dose
- 990 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- SOCRATEC R&D GMBH
- Paediatric formulation
- No
- Orphan designation
- No
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
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 |
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_EFTS_2023-503609-12-00 SUM-63043
|
2024-12-13T14:59:57 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Layperson Summary_EFTS_2023-503609-12-00 | 2024-12-13T14:59:11 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layperson Summary_EFTS_2023-503609-12-00_redacted | 1 |
| Summary of results (for publication) | Summary of results_EFTS_2023-503609-12-00_redacted | 1 |
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 |