- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794923
Topical Ibuprofen for Delayed Onset Mulscle Soreness
PLACEBO-CONTROLLED, DOUBLE-BLIND EVALUATION OF THE EFFICACY AND SAFETY OF IBUPROFEN 5% TOPICAL GEL FOR THE TREATMENT OF DELAYED-ONSET MUSCLE SORENESS OF THE ELBOW FLEXOR MUSCLES
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19145
- Institute for Applied Pharmaceutical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the study
Exclusion Criteria:
Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ibuprofen 5% topical gel BID
IBU BID (Treatment A)
|
10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days
|
Placebo Comparator: Placebo topical gel BID
Placebo BID (Treatment B)
|
10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days
|
Experimental: Ibuprofen 5% topical gel TID
IBU TID (Treatment C)
|
10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days
|
Placebo Comparator: Placebo topical gel TID
Placebo TID (Treatment D)
|
10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 0-24 Hours Post-Dose 1 (MSM 0-24 )
Time Frame: Baseline, 0 to 24 hours post-Dose 1 on Day 1
|
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM).
Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity.
Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).
|
Baseline, 0 to 24 hours post-Dose 1 on Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Time-Weighted Sum of Muscle Soreness With Movement Over 24-48 Hours, 48-72 Hours, 0-72 Hours Post-Dose 1
Time Frame: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1
|
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM.
Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher scores=more severity.
Change from baseline in the time-weighted sum of MSM over 24-48 hours, 48-72 hours and 0-72 hours were derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 24 to Hour 48 (range: -96 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -96 to 240, higher score indicates better outcome); and Hour 0 to Hour 72 (range: -288 to 720, higher score indicates better response).
|
Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1
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Change From Baseline in Muscle Soreness With Movement at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
Time Frame: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
|
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate MSM.
Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11-point scale ranging from 0 to 10, where 0=not sore' and 10=extremely sore, higher score=more severity.
|
Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
|
Change From Baseline in the Time-weighted Sum of Spontaneous Muscle Soreness Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours Post-Dose 1
Time Frame: Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1
|
Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate MSM.
Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity.
Change from baseline in time-weighted sum of SMS over 0-24 hours (hr.), 24-48 hr., 48-72 hr. and 0-72 hr. were derived as the SMS change from baseline multiplied by time elapsed since the previous assessment and summed overall assessment from Hour 0 to Hour 24 (range: -240 to 240, higher score indicates better response), Hour 24 to Hour 48 (range: -240 to 240, higher score indicates better response); Hour 48 to Hour 72 (range: -240 to 240, higher score indicates better response); and Hour 0 to Hour 72 (range: -720 to 720, higher score indicates better response).
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Baseline, 24 to 48, 48 to 72, 0 to 72 hours post-Dose 1 on Day 1
|
Change From Baseline in Spontaneous Muscle Soreness at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 Hours Post-Dose 1
Time Frame: Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
|
Participants after sitting quietly for 3 minutes, were asked to extend the arm that was exercised earlier to stimulate SMS.
Participants were asked to rate their degree of SMS, using an 11-point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity.
|
Baseline,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
|
Time-weighted Sum of Muscle Soreness Relief Over 0-24 Hours, 24-48 Hours, 48-72 Hours, and 0-72 Hours
Time Frame: 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1
|
Participants were asked: "Which phrase best describes the relief of muscle soreness which you are experiencing?"
Participant's response were recorded using a five-point scale: 0=None, 1=A little, 2=Some, 3=A lot and 4=Complete relief.
Time-weighted sum of muscle soreness relief over 0-24 hours, 24-48 hours, 48-72 hours, and 0-72 hours were derived as the muscle soreness relief score multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (total score range: 0 [none] to 96 [complete relief], higher score indicates better response), Hour 24 to Hour 48 (range: 0 to 96, higher score indicates better response); Hour 48 to Hour 72 (range: 0 to 96, higher score indicates better response); and Hour 0 to Hour 72 (range: 0 to 288, higher score indicates better response).
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0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1
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Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1
Time Frame: Baseline, 24 hours post-Dose 1
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Participants were asked to rate their SMSM, using an 11-point scale, with 0=not stiff and 10=extremely stiff, higher score indicated more severity.
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Baseline, 24 hours post-Dose 1
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Muscle Soreness Relief at Each Time Point
Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
|
Participants were asked: "Which phrase best describes the relief of muscle soreness which you are experiencing?"
Participant's response was recorded using a five-point scale: 0 = None, 1 = A little, 2 = Some, 3 = A lot and 4 = Complete, higher scores indicated better response/more relief.
|
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 30, 36, 48, 54, 60 and 72 hours post-Dose 1 on Day 1
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Participant's Global Assessment of Medication at Day 4
Time Frame: Day 4
|
Participants were asked the following question: "How would you rate this medication as a pain reliever?"
Participant's response was recorded using a five point scale: 1 = Very Poor, 2 = Poor, 3 = Fair, 4 = Good, 5 = Very Good, where higher score indicated better response.
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Day 4
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Percentage of Participants Taking Rescue Medication
Time Frame: Baseline up to Day 4
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Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
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Baseline up to Day 4
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Time to First Use of Rescue Medication
Time Frame: Baseline up to Day 4
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Time to first us of rescue medication was defined as time (in hours) from a dose of study medication to the first use of recue medication and was censored at the time of the next dose of study medication, or at 12 hours after the final application of the study medication.
Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
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Baseline up to Day 4
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Number of Doses of Rescue Medication
Time Frame: Baseline up to Day 4
|
Acetaminophen 500 milligram (mg) every 6 hours as needed was used as rescue analgesia/therapy during the course of the study.
|
Baseline up to Day 4
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B3491010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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