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NCT05171673
Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury
Phase 3 trial testing Licart™ (diclofenac epolamine) topical system in Soft Tissue Injuries in 151 participants. Completed in 12 July 2024.
30 June 2024
Quick facts
| Lead sponsor | IBSA Institut Biochimique SA |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 151 |
| Start date | 31 October 2021 |
| Primary completion | 30 June 2024 |
| Estimated completion | 12 July 2024 |
| Sites | 11 locations across United States |
Drugs / interventions tested
- Licart™ (diclofenac epolamine) topical system — full drug profile →
Conditions studied
- Soft Tissue Injuries — all drugs for Soft Tissue Injuries →
Sponsor
IBSA Institut Biochimique SA — full company profile →
Who can join
Adults 6 to 45, any sex, with Soft Tissue Injuries. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A multi-center, prospective, open-label, controlled study of the pharmacokinetics and safety of the LicartTM topical system in pediatric and adult participants with minor soft tissue injuries. 150 male and female participants aged 6-16 and 18-45 with soft tissue injuries meeting the following criteria will be enrolled to evaluate the pharmacokinetics and safety of the Licart topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. The analgesic effects will also be evaluated of the topical system in pediatric and adult participants with minor soft tissue injuries over a 14-day treatment course. To collect principal investigator-reported global response to therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05171673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Soft Tissue Injuries
Currently open trials in the same condition.
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Other IBSA Institut Biochimique SA trials
Trials by the same sponsor.
- NCT06659692 — Pharmacokinetics of FSH and hCG Following Multiple Dose of Gonadotropins-IBSA. · Phase 1 · completed
- NCT06781957 — Pharmacokinetics of FSH and hCG After a Single Subcutaneous Injection of Gonadotropins-IBSA · Phase 1 · completed
- NCT05490680 — A New Sildenafil Oral Film in Patients With Erectile Dysfunction · Phase 3 · completed
- NCT04549116 — Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer. · Phase 3 · active not recruiting
- NCT05228184 — Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH) · Phase 4 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05171673 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IBSA Institut Biochimique SA
- Last refreshed: 10 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05171673.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing