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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 is a Phase 3 study that has completed, run by IBSA Institut Biochimique. The registered enrollment target is 151 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05171673
The ClinicalTrials.gov registry entry for NCT05171673 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IBSA Institut Biochimique, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Licart™ (diclofenac epolamine) topical system is the first listed.
NCT05171673 reports 0 study locations.
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.
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