Phase 3
Completed N=242
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Grade I/II Ankle Sprain
Source: ClinicalTrials.gov NCT00955513 ↗
Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Measure: Pain on Movement on Day 5 (Change From Baseline). — 49.1; 49.7; 25.4 mm
Summary
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure: Pain on Movement on Day 5 (Change From Baseline). |
49.1; 49.7; 25.4 | — |
Eligibility Criteria
Inclusion Criteria
- Acute sprain of the lateral ankle, Grade I-II .
Exclusion Criteria
- Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
Data sourced from ClinicalTrials.gov (NCT00955513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.