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NCT01945034 · ClinicalTrials.gov registry record · Phase 3
5% Topical Ibuprofen (IBU) for Ankle Sprain
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
NCT01945034: Completed Phase 3 study, sponsored by Pfizer.
NCT01945034 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 304 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945034, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.
Primary Outcome
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at po
Interventions
- DRUG Placebo twice daily
- DRUG Topical IBU twice daily
- DRUG Topical IBU three times daily
- DRUG Placebo three times daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01945034 record still lists
NCT01945034 is an interventional study that assigns participants to a tested intervention. The registered 304 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 (61% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo twice daily is the first listed.
NCT01945034 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01945034 about?
NCT01945034 is a clinical study titled "5% Topical Ibuprofen (IBU) for Ankle Sprain". This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.
What is the current status of trial NCT01945034?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2013-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01945034?
The interventions under investigation include: Placebo twice daily (DRUG), Topical IBU twice daily (DRUG), Topical IBU three times daily (DRUG), Placebo three times daily (DRUG).
Who is sponsoring clinical trial NCT01945034?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01945034's enrollment target sits among peer trials
304 1117th of 2000 higher than 882 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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