# Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

> **NCT01255423** · PHASE3 · COMPLETED · sponsor: **Novartis** · enrollment: 206 (actual)

## Conditions studied

- Ankle Sprain

## Interventions

- **DRUG:** Diclofenac sodium topical gel 1%
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01255423
- **Lead sponsor:** Novartis
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-11
- **Primary completion:** 2011-06
- **Final completion:** 2011-06
- **Target enrollment:** 206 (ACTUAL)
- **Last updated:** 2012-10-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01255423

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01255423, "Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT01255423. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
