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Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate

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ClinicalTrials.gov Identifier: NCT01454791
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : February 13, 2015
Last Update Posted : March 5, 2015
Sponsor:
Collaborator:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Brown, Theodore R., M.D., MPH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Multiple Sclerosis
Interventions Drug: diclofenac sodium topical gel
Other: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac Sodium Topical Gel Followed by Placebo Placebo Followed by Diclofenac Sodium Topical Gel
Hide Arm/Group Description

diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo

Placebo: a placebo gel is applied 1-4 times per day for two weeks.

Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks

Placebo: a placebo gel is applied 1-4 times per day for two weeks.

Period Title: Overall Study
Started 20 20
Completed 20 [1] 20 [2]
Not Completed 0 0
[1]
20 subjects started with Diclofenac, then switched to placebo
[2]
20 subjects started with placebo, then switched to Diclofenac
Arm/Group Title Diclofenac Sodium Topical Gel Followed by Placebo Placebo Followed by Diclofenac Sodium Gel Total
Hide Arm/Group Description

diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo

Placebo: a placebo gel is applied 1-4 times per day for two weeks.

placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks

Placebo: a placebo gel is applied 1-4 times per day for two weeks.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  95.0%
19
  95.0%
38
  95.0%
>=65 years
1
   5.0%
1
   5.0%
2
   5.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
16
  80.0%
17
  85.0%
33
  82.5%
Male
4
  20.0%
3
  15.0%
7
  17.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
Hide Description patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint
Arm/Group Title Diclofenac Sodium Topical Gel Placebo
Hide Arm/Group Description:
diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.39  (0.19) 3.47  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Sodium Topical Gel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.08
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pain Scale at 2 Weeks
Hide Description 0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint
Arm/Group Title Diclofenac Sodium Topical Gel Placebo
Hide Arm/Group Description:
diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
Placebo for 2 weeks: a placebo gel is applied 1-4 times per day
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.44  (0.28) 2.60  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Sodium Topical Gel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6059
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.16
Estimation Comments not significant
3.Secondary Outcome
Title Subject Global Impression at 2 Weeks
Hide Description This is a single question: "How would you rate your level of comfort with Copaxone injection during the past two weeks?" Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint
Arm/Group Title Diclofenac Sodium Topical Gel Placebo
Hide Arm/Group Description:
diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
Placebo for two weeks: a placebo gel is applied 1-4 times per day
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Likert scale 1-7 (7= best)
4.68  (0.17) 4.50  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Sodium Topical Gel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Estimation Comments not significant
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclofenac Sodium Topical Gel Placebo
Hide Arm/Group Description

1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo

Placebo: a placebo gel is applied 1-4 times per day for two weeks.

1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo

Placebo: a placebo gel is applied 1-4 times per day for two weeks.

All-Cause Mortality
Diclofenac Sodium Topical Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Sodium Topical Gel Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diclofenac Sodium Topical Gel Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/20 (5.00%)    
Skin and subcutaneous tissue disorders     
urticaria *  0/20 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Theodore R, Brown, MD Principle Investigator
Organization: MS Center at Evergreenhealth Care
Phone: 425-899-5350
Responsible Party: Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier: NCT01454791     History of Changes
Other Study ID Numbers: WIRB 20101775
First Submitted: August 9, 2011
First Posted: October 19, 2011
Results First Submitted: July 22, 2014
Results First Posted: February 13, 2015
Last Update Posted: March 5, 2015