Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01874626 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain
A Phase 3 study, sponsored by Strategic Science & Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 305
- Enrollment target
NCT01874626: Completed Phase 3 study, sponsored by Strategic Science & Technologies.
NCT01874626 is a Phase 3 study that has completed, run by Strategic Science & Technologies. The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01874626, a Phase 3 study, has completed, sponsored by Strategic Science & Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 305 participants
- Enrollment target
Study Summary
This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be randomized into the study and will receive either the active treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount equivalent to a 4 inch line of investigational product to the affected ankle approximately every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a 24 hour period. Duration of treatment with the investigational product is 7 days.
Primary Outcome
Tme weighted summed pain intensity on movement difference from baseline over the first 24 hours (SPID24) following the first application of study medication on Day 1
Interventions
- DRUG Placebo
- DRUG SST-0225 Topical Ibuprofen Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 305 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01874626 record still lists
NCT01874626 is an interventional study that assigns participants to a tested intervention. The registered 305 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 (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01874626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01874626 about?
NCT01874626 is a clinical study titled "Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain". This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be random...
What is the current status of trial NCT01874626?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2013-06. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01874626?
The interventions under investigation include: Placebo (DRUG), SST-0225 Topical Ibuprofen Cream (DRUG).
Who is sponsoring clinical trial NCT01874626?
This trial is sponsored by Strategic Science & Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01874626's enrollment target sits among peer trials
305 1117th of 2000 higher than 884 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04107181 · 305 participants · NA
Pilot Study for Speculum Free Cervical Cancer Screening
- NCT05399056 · 305 participants · NA
Improving Participation in Pulmonary Rehabilitation Through Peer Support and Storytelling
- NCT05078970 · 306 participants · NA
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
- NCT05843695 · 306 participants · NA
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia