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NCT05171673 · ClinicalTrials.gov registry record · Phase 3
Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury
A Phase 3 study, sponsored by IBSA Institut Biochimique.
- Completed
- Registry status
- Phase 3
- Development phase
- 151
- Enrollment target
NCT05171673: Completed Phase 3 study, sponsored by IBSA Institut Biochimique.
NCT05171673 is a Phase 3 study that has completed, run by IBSA Institut Biochimique. The registered enrollment target is 151 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05171673, a Phase 3 study, has completed, sponsored by IBSA Institut Biochimique.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 151 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Plasma diclofenac concentration, 24hours after initial topical system application (V2 and V5/EOS)
Interventions
- DRUG Licart™ (diclofenac epolamine) topical system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2021-10-31 |
| Est. Completion | 2024-07-12 |
| Phase | Phase 3 |
What the finished NCT05171673 record still lists
NCT05171673 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Licart™ (diclofenac epolamine) topical system is the first listed.
NCT05171673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05171673 about?
NCT05171673 is a clinical study titled "Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury". 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 criter...
What is the current status of trial NCT05171673?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 151 participants. The study started on 2021-10-31. Estimated completion is 2024-07-12.
What interventions are being tested in trial NCT05171673?
The interventions under investigation include: Licart™ (diclofenac epolamine) topical system (DRUG).
Who is sponsoring clinical trial NCT05171673?
This trial is sponsored by IBSA Institut Biochimique, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05171673's enrollment target sits among peer trials
151 1517th of 2000 higher than 482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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