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Trial record 17 of 456 for:    DICLOFENAC

The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01383954
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : July 6, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Intervention Drug: Diclofenac Gel
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac Gel
Hide Arm/Group Description Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Period Title: Overall Study
Started 52
Safety Population: Received Treatment 48
Completed [1] 38
Not Completed 14
Reason Not Completed
Lack of Efficacy             2
Electronic Diary Too Cumbersome to Use             2
Adverse Event             1
Reason Not Specified             9
[1]
Completed = completed at least 2 weeks of being on study medication
Arm/Group Title Diclofenac Gel
Hide Arm/Group Description Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
56.8  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
23
  60.5%
Male
15
  39.5%
1.Primary Outcome
Title Percent Change From Baseline in Pain Score During Week 1
Hide Description Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.
Time Frame Baseline and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.
Arm/Group Title Diclofenac Gel
Hide Arm/Group Description:
Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: percent change
33.3  (23.7)
2.Primary Outcome
Title Percent Change From Baseline in Pain Score During Week 2
Hide Description Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.
Time Frame Baseline and Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.
Arm/Group Title Diclofenac Gel
Hide Arm/Group Description:
Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: percent change
33.3  (23.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Gel
Hide Arm/Group Description Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
All-Cause Mortality
Diclofenac Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Gel
Affected / at Risk (%)
Total   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Diclofenac Gel
Affected / at Risk (%)
Total   1/48 (2.08%) 
Skin and subcutaneous tissue disorders   
Rash  1/48 (2.08%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ajay D. Wasan, M.D., M.Sc.
Organization: Brigham and Women's Hospital
EMail: awasan@partners.org
Layout table for additonal information
Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01383954     History of Changes
Other Study ID Numbers: 2009p000667
First Submitted: June 22, 2011
First Posted: June 28, 2011
Results First Submitted: April 5, 2017
Results First Posted: July 6, 2017
Last Update Posted: August 15, 2017