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Trial record 84 of 346 for:    sprains and strains

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

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ClinicalTrials.gov Identifier: NCT00573768
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : November 18, 2010
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankle Sprain
Interventions Drug: Diclofenac diethylamine 2.32% gel
Drug: Placebo
Drug: Diclofenac diethylamine 2.32% gel / Placebo
Enrollment 271
Recruitment Details Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices
Pre-assignment Details  
Arm/Group Title Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel
Hide Arm/Group Description Twice daily (BID) application Once daily (OD) application of active gel and OD application of vehicle gel BID application
Period Title: Overall Study
Started 89 91 91
Completed 87 89 87
Not Completed 2 2 4
Reason Not Completed
Adverse Event             1             1             2
Protocol Violation             1             0             1
Withdrawal by Subject             0             1             0
Lost to Follow-up             0             0             1
Arm/Group Title Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel Total
Hide Arm/Group Description Twice daily (BID) application Once daily (OD) application of active gel and OD application of vehicle gel BID application Total of all reporting groups
Overall Number of Baseline Participants 89 91 91 271
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 91 participants 91 participants 271 participants
38.8  (13.7) 38.2  (14.6) 38.9  (14.1) 38.6  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 91 participants 91 participants 271 participants
Female
49
  55.1%
47
  51.6%
46
  50.5%
142
  52.4%
Male
40
  44.9%
44
  48.4%
45
  49.5%
129
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 89 participants 91 participants 91 participants 271 participants
89 91 91 271
1.Primary Outcome
Title Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
Hide Description Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)
Time Frame change from baseline (on day 1) to day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT)
Arm/Group Title Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel
Hide Arm/Group Description:
Twice daily (BID) application
Once daily (OD) application of active gel and OD application of vehicle gel
BID application
Overall Number of Participants Analyzed 89 91 91
Mean (Standard Deviation)
Unit of Measure: mm
38.3  (22.7) 35.7  (20.4) 33.4  (20.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel
Hide Arm/Group Description Twice daily (BID) application Once daily (OD) application of active gel and OD application of vehicle gel BID application
All-Cause Mortality
Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/91 (0.00%)   0/91 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac Diethylamine (DDEA) 2.32% Gel BID DDEA 2.32% Gel OD Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/89 (3.37%)   6/91 (6.59%)   1/91 (1.10%) 
Nervous system disorders       
headache  3/89 (3.37%)  6/91 (6.59%)  1/91 (1.10%) 
1
Term from vocabulary, MedDra 10.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Sandy Hamelsky
Organization: Novartis Consumer Health
Phone: +19735037258
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00573768     History of Changes
Other Study ID Numbers: VOPO-PE-201
First Submitted: December 13, 2007
First Posted: December 14, 2007
Results First Submitted: July 28, 2010
Results First Posted: November 18, 2010
Last Update Posted: April 20, 2012