Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
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
1 other identifier
interventional
242
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2009
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 7, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 26, 2011
CompletedApril 20, 2012
January 1, 2011
5 months
August 7, 2009
December 1, 2010
April 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
diclofenac diethylamine gel 2.32% gel twice a day
EXPERIMENTALdrug
diclofenac diethylamine gel 2.32% gel three times a day
EXPERIMENTALdrug
placebo
PLACEBO COMPARATORplacebo
Interventions
diclofenac diethylamine gel 2.32% twice a day
Eligibility Criteria
You may qualify if:
- \. Acute sprain of the lateral ankle, Grade I-II .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (5)
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Gilching, Germany
Novartis Investigative Site
Grünwald, Germany
Novartis Investigative Site
München, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Leader Pain category
- Organization
- Novartis Consumer Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2009
First Posted
August 10, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
April 20, 2012
Results First Posted
January 26, 2011
Record last verified: 2011-01