Topical Ibuprofen for Delayed Onset Mulscle Soreness

Pfizer205 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

205

Conditions

Pain

Interventions

IBU BIDDRUG

10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days

Placebo BIDDRUG

10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days

IBU TIDDRUG

10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institute for Applied Pharmaceutical Research

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline, 0 to 24 hours post-Dose 1 on Day 1

Secondary Outcomes

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).

Time frame: 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

Data from ClinicalTrials.gov

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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).

Time frame: Baseline, 24 to 48, 48 to 72, 0 to 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).

Time frame: 0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1