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NCT02324270 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 658
- Enrollment target
NCT02324270: Completed Phase 3 study, sponsored by Actavis.
NCT02324270 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 658 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02324270, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 658 participants
- Enrollment target
Study Summary
To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain
Primary Outcome
To evaluate the therapeutic equivalence (90% CI) of generic diclofenac epolamine 1.3% patch (Watson Laboratories, Inc.) and Flector® (diclofenac epolamine 1.3% patch) (Pfizer) using a 100mm VAS scoring in the treatment of acute pain due to minor ankle sprain (in the per protocol population); changes from baseline. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as lower values of 'no pain at all' and higher values relating to 'pain as
Interventions
- OTHER Placebo
- DRUG Diclofenac epolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 658 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT02324270 record still lists
NCT02324270 is an interventional study that assigns participants to a tested intervention. The registered 658 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 (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02324270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02324270 about?
NCT02324270 is a clinical study titled "Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain". To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain
What is the current status of trial NCT02324270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 658 participants. The study started on 2014-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02324270?
The interventions under investigation include: Placebo (OTHER), Diclofenac epolamine (DRUG).
Who is sponsoring clinical trial NCT02324270?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02324270's enrollment target sits among peer trials
658 563rd of 2000 higher than 1,437 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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