Trial Outcomes & Findings for An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS (NCT NCT02087748)
NCT ID: NCT02087748
Last Updated: 2014-12-10
Results Overview
The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (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 "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).
COMPLETED
PHASE4
24 participants
7 days
2014-12-10
Participant Flow
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.
Participant milestones
| Measure |
1% Diclofenac Sodium Gel
Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS
Baseline characteristics by cohort
| Measure |
1% Diclofenac Sodium Gel
n=24 Participants
Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 3.58 • n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (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 "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).
Outcome measures
| Measure |
1% Diclofenac Sodium Gel
n=24 Participants
Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours
1% diclofenac sodium gel
|
Placebo
n=24 Participants
Placebo gel 4gm applied topically Q6H for 48 hours
Placebo: gel manufactured to mimic Diclofenac sodium1% gel
|
|---|---|---|
|
Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours
|
34.87 units on a scale
Standard Deviation 22.86
|
23.62 units on a scale
Standard Deviation 19.38
|
SECONDARY outcome
Timeframe: 7 daysThe 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).
Outcome measures
| Measure |
1% Diclofenac Sodium Gel
n=24 Participants
Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours
1% diclofenac sodium gel
|
Placebo
n=24 Participants
Placebo gel 4gm applied topically Q6H for 48 hours
Placebo: gel manufactured to mimic Diclofenac sodium1% gel
|
|---|---|---|
|
Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours
|
28.06 units on a scale
Standard Deviation 23.84
|
24.81 units on a scale
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 7 daysThe 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).
Outcome measures
| Measure |
1% Diclofenac Sodium Gel
n=24 Participants
Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours
1% diclofenac sodium gel
|
Placebo
n=24 Participants
Placebo gel 4gm applied topically Q6H for 48 hours
Placebo: gel manufactured to mimic Diclofenac sodium1% gel
|
|---|---|---|
|
Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours
|
33.9 units on a scale
Standard Deviation 23.29
|
21.62 units on a scale
Standard Deviation 18.8
|
Adverse Events
1% Diclofenac Sodium Gel
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne Arriaga, VP of Clinical Operations
Lotus Clinical Research, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place