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OpenTrials
Completed

NCT Number: NCT01794923

Topical Ibuprofen for Delayed Onset Mulscle Soreness

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute for Applied Pharmaceutical Research

Philadelphia, Pennsylvania, 19145, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBU BID

Drug

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

placebo bid

Drug

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

IBU TID

Drug

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

Placebo TID

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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

    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.

  7. 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.

  8. 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.

  9. Percentage of Participants Taking 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.

  10. Time to First Use of Rescue Medication

    Time frame: Baseline up to Day 4

    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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 20, 2013
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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