Topical Ibuprofen for Delayed Onset Mulscle Soreness

NCT01794923 | Completed Phase 3 Results

• 1 other identifier: B3491010
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Delayed onset muscle soreness; ibuprofen; topical

Outcome Measures

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 )

  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 Outcomes (11)

• 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

  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

  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

  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

  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

  0 to 24, 24 to 48, 48 to 72 and 0 to 72 hours on Day 1

Study Arms (4)

Ibuprofen 5% topical gel BID

EXPERIMENTAL

IBU BID (Treatment A)

Drug: IBU BID

Placebo topical gel BID

PLACEBO COMPARATOR

Placebo BID (Treatment B)

Drug: Placebo BID

Ibuprofen 5% topical gel TID

EXPERIMENTAL

IBU TID (Treatment C)

Drug: IBU TID

Placebo topical gel TID

PLACEBO COMPARATOR

Placebo TID (Treatment D)

Drug: Placebo TID

Interventions

IBU BID DRUG

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

Ibuprofen 5% topical gel BID

Placebo BID DRUG

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

Placebo topical gel BID

IBU TID DRUG

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

Ibuprofen 5% topical gel TID

Placebo TID DRUG

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

Placebo topical gel TID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Institute for Applied Pharmaceutical Research

Philadelphia, Pennsylvania, 19145, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 20, 2013
• Study Start: June 13, 2013
• Primary Completion: March 29, 2014
• Study Completion: March 29, 2014
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)