Topical Ibuprofen for Delayed Onset Mulscle Soreness

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the efficacy and safety of Ibuprofen 5% Topical Gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.

Official Title
-----------------
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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: IBU BID
* Drug: Placebo BID
* Drug: IBU TID
* Drug: Placebo TID


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen 5% topical gel BID<br>IBU BID (Treatment A) | Drug: IBU BID<br>* 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days<br>|
| Placebo Comparator: Placebo topical gel BID<br>Placebo BID (Treatment B) | Drug: Placebo BID<br>* 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days<br>|
| Experimental: Ibuprofen 5% topical gel TID<br>IBU TID (Treatment C) | Drug: IBU TID<br>* 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days<br>|
| Placebo Comparator: Placebo topical gel TID<br>Placebo TID (Treatment D) | Drug: Placebo TID<br>* 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days<br>|

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 ) | 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 | 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 | 
| 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 | 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 | 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). | 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 | 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 | 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). | 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1 | 
| Change From Baseline in Stiffness During Muscle Soreness With Movement (SMSM) Assessment at 24 Hours Post-Dose 1 | 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. | Baseline, 24 hours post-Dose 1 | 
| Muscle Soreness Relief at Each Time Point | 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 | 
| Participant's Global Assessment of Medication at 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. | Day 4 | 
| Percentage of Participants Taking Rescue Medication | 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 | 
| Time to First Use of Rescue Medication | 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. | Baseline up to Day 4 | 
| Number of Doses of Rescue Medication | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ibuprofen, Delayed onset muscle soreness, topical