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Completed

NCT Number: NCT00573768

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

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Key information

Conditions

Ankle Sprain Ankle Injuries Leg Injuries Sprains and Strains Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Bad Bramstedt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac diethylamine 2.32% gel

Drug

Diclofenac diethylamine 2.32% gel twice daily

Placebo

Drug

Vehicle 2 times daily

Diclofenac diethylamine 2.32% gel / Placebo

Drug

Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Primary outcomes

  1. Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.

    Time frame: change from baseline (on day 1) to day 5

    Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Once or Twice Daily in Patients With Acute Ankle Sprain

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Dec 14, 2007
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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