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 Clinical Trial

Official title:

A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955513
• Other study ID #: VOPO-P-307
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2009
• Last updated: April 18, 2012
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Acute sprain of the lateral ankle, Grade I-II .

Exclusion Criteria:

1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.

2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Grade I/II Ankle Sprain

Intervention

Drug:
• diclofenac diethylamine gel 2.32%
diclofenac diethylamine gel 2.32% twice a day
• diclofenac diethylamine gel 2.32%
diclofenac diethylamine gel 2.32% three times a day
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Cologne
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Gilching
Germany	Novartis Investigative Site	Grunwald
Germany	Novartis Investigative Site	Munchen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Pain on Movement on Day 5 (Change From Baseline).	Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.	baseline and day 5	No