Status:
COMPLETED
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Lead Sponsor:
Novartis
Conditions:
Grade I/II Ankle Sprain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ank...
Eligibility Criteria
Inclusion
- 1\. Acute sprain of the lateral ankle, Grade I-II .
Exclusion
- Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00955513
Start Date
July 1 2009
End Date
December 1 2009
Last Update
April 20 2012
Active Locations (5)
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1
Novartis Investigative Site
Cologne, Germany
2
Novartis Investigative Site
Essen, Germany
3
Novartis Investigative Site
Gilching, Germany
4
Novartis Investigative Site
Grünwald, Germany