Clinical trial NCT00573768: Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankle Sprain
Keywords: Ankle, sprain, diclofenac diethylamine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
timeFrame: change from baseline (on day 1) to day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Bramstedt
country: Germany
facility: Novartis Investigative Site
city: Bad Nauheim
country: Germany
facility: Novartis Investigative Site
city: Bad Zwischenahn
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dusseldorf
country: Germany
facility: Novartis Investigative Site
city: Eichstätt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hammelburg
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kaufbeuren
country: Germany
facility: Novartis Investigative Site
city: Lambrecht/Pfalz
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Meersburg
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
city: Neustadt/Aisch
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Stockach
country: Germany
facility: Novartis Investigative Site
Study officials:
name: Axel Baltzer
role: PRINCIPAL_INVESTIGATOR
References: