Phase 2
N=271
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
Ankle Sprain
Bottom Line
View on ClinicalTrials.gov: NCT00573768 ↗Enrolled (actual)
271
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. — 38.3; 35.7; 33.4 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Diclofenac diethylamine 2.32% gel (Drug); Placebo (Drug); Diclofenac diethylamine 2.32% gel / Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. |
38.3; 35.7; 33.4 | — |
Summary
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
Eligibility Criteria
Inclusion Criteria
- Acute sprain of the ankle
- Injury within past 48 hours.
Exclusion Criteria
- Pain medication taken since the injury
- Pain or instability in the same ankle due to previous ankle sprain or any other trauma.
- Ankle sprain due to a known disease affecting the ligaments
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00573768). 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.