Back to resultsEvaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Primary Purpose
Grade I/II Ankle Sprain
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
diclofenac diethylamine gel 2.32%
diclofenac diethylamine gel 2.32%
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Grade I/II Ankle Sprain focused on measuring Ankle sprain, soft tissue injury
Eligibility Criteria
Inclusion Criteria:
1. Acute sprain of the lateral ankle, Grade I-II .
Exclusion Criteria:
- 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
diclofenac diethylamine gel 2.32% gel twice a day
diclofenac diethylamine gel 2.32% gel three times a day
placebo
Arm Description
drug
drug
placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00955513
Brief Title
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 ankle sprains (distortions).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade I/II Ankle Sprain
Keywords
Ankle sprain, soft tissue injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
242 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diclofenac diethylamine gel 2.32% gel twice a day
Arm Type
Experimental
Arm Description
drug
Arm Title
diclofenac diethylamine gel 2.32% gel three times a day
Arm Type
Experimental
Arm Description
drug
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
diclofenac diethylamine gel 2.32%
Intervention Description
diclofenac diethylamine gel 2.32% twice a day
Intervention Type
Drug
Intervention Name(s)
diclofenac diethylamine gel 2.32%
Intervention Description
diclofenac diethylamine gel 2.32% three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Measure: Pain on Movement on Day 5 (Change From Baseline).
Description
Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.
Time Frame
baseline and day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Acute sprain of the lateral ankle, Grade I-II .
Exclusion Criteria:
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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Cologne
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Gilching
Country
Germany
Facility Name
Novartis Investigative Site
City
Grunwald
Country
Germany
Facility Name
Novartis Investigative Site
City
Munchen
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
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