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Topical Ibuprofen for Delayed Onset Mulscle Soreness

NCT01794923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2021-09-30

Study results available
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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

Interventions

DRUG

IBU BID

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

DRUG

Placebo BID

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

DRUG

IBU TID

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

DRUG

Placebo TID

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-13
Primary Completion
2014-03-29
Completion
2014-03-29

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01794923 on ClinicalTrials.gov