Topical Ibuprofen for Delayed Onset Mulscle Soreness

NCT ID: NCT01794923

Last Updated: 2021-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-13

Study Completion Date

2014-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ibuprofen 5% topical gel BID

IBU BID (Treatment A)

Group Type EXPERIMENTAL

IBU BID

Intervention Type DRUG

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

Placebo topical gel BID

Placebo BID (Treatment B)

Group Type PLACEBO_COMPARATOR

Placebo BID

Intervention Type DRUG

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

Ibuprofen 5% topical gel TID

IBU TID (Treatment C)

Group Type EXPERIMENTAL

IBU TID

Intervention Type DRUG

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

Placebo topical gel TID

Placebo TID (Treatment D)

Group Type PLACEBO_COMPARATOR

Placebo TID

Intervention Type DRUG

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

Interventions

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IBU BID

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

Intervention Type DRUG

Placebo BID

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

Intervention Type DRUG

IBU TID

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

Intervention Type DRUG

Placebo TID

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Institute for Applied Pharmaceutical Research

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B3491010

Identifier Type: -

Identifier Source: org_study_id

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