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NCT01255423 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
NCT01255423: Completed Phase 3 study, sponsored by Novartis.
NCT01255423 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01255423, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Primary Outcome
Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"
Interventions
- DRUG Placebo
- DRUG Diclofenac sodium topical gel 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT01255423 record still lists
NCT01255423 is an interventional study that assigns participants to a tested intervention. The registered 206 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 (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01255423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01255423 about?
NCT01255423 is a clinical study titled "Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain". The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
What is the current status of trial NCT01255423?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2010-11. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01255423?
The interventions under investigation include: Placebo (DRUG), Diclofenac sodium topical gel 1% (DRUG).
Who is sponsoring clinical trial NCT01255423?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01255423's enrollment target sits among peer trials
206 1347th of 2000 higher than 651 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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