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An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS

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ClinicalTrials.gov Identifier: NCT02087748
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Neil Singla, Lotus Clinical Research, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Pain
Delayed Onset Muscle Soreness
Interventions Drug: 1% diclofenac sodium gel
Drug: Placebo
Enrollment 24
Recruitment Details

Dates of recruitment period: First subject was enrolled in March 2014 and the last subject was enrolled in April 2014.

Types of location: Investigative site was located at one research center.

Pre-assignment Details  
Arm/Group Title 1% Diclofenac Sodium Gel
Hide Arm/Group Description Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title 1% Diclofenac Sodium Gel
Hide Arm/Group Description Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
One group will use 1% diclofenac sodium gel on the left leg and placebo on the right leg for the treatment duration. The other group will use the same products, but on opposite legs.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
28.0  (3.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
9
  37.5%
Male
15
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
7
  29.2%
Not Hispanic or Latino
17
  70.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  37.5%
White
13
  54.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Diclofenac Sodium Gel Placebo
Hide Arm/Group Description:

Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours

1% diclofenac sodium gel

Placebo gel 4gm applied topically Q6H for 48 hours

Placebo: gel manufactured to mimic Diclofenac sodium1% gel

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
34.87  (22.86) 23.62  (19.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Diclofenac Sodium Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0324
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours
Hide Description

The secondary outcome is the mean reduction in DOMS scores at rest in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.

Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain).

Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Diclofenac Sodium Gel Placebo
Hide Arm/Group Description:

Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

Placebo gel 4gm applied topically Q6 hour for 48 hours

Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.06  (23.84) 24.81  (20.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Diclofenac Sodium Gel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3688
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours
Hide Description

The secondary outcome is the mean reduction in DOMS scores while standing in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.

Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain).

Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Diclofenac Sodium Gel Placebo
Hide Arm/Group Description:

Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours

Placebo gel 4gm applied topically Q6 hour for 48 hours

Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
33.9  (23.29) 21.62  (18.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1% Diclofenac Sodium Gel, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0275
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description For serious adverse events, events will be collected when identified from the date Subject signed Informed Consent up to 30 days after discontinuation from the study. For other adverse events, events will be collected until study completion or early termination.
 
Arm/Group Title 1% Diclofenac Sodium Gel Placebo
Hide Arm/Group Description

Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours

1% diclofenac sodium gel

Placebo gel 4gm applied topically Q6H for 48 hours

Placebo: gel manufactured to mimic Diclofenac sodium1% gel

All-Cause Mortality
1% Diclofenac Sodium Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1% Diclofenac Sodium Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1% Diclofenac Sodium Gel Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
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: Anne Arriaga, VP of Clinical Operations
Organization: Lotus Clinical Research, LLC
Phone: 626-397-3412
EMail: anne@lotuscr.com
Layout table for additonal information
Responsible Party: Neil Singla, Lotus Clinical Research, LLC
ClinicalTrials.gov Identifier: NCT02087748     History of Changes
Other Study ID Numbers: LCR-VOL-01C
First Submitted: March 12, 2014
First Posted: March 14, 2014
Results First Submitted: October 1, 2014
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014