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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 is a Phase 3 study that has completed, run by Strategic Science & Technologies. The registered enrollment target is 305 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01874626
The ClinicalTrials.gov registry entry for NCT01874626 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 305 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Strategic Science & Technologies, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01874626 reports 0 study locations.
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.
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