Topical Ibuprofen for Delayed Onset Mulscle Soreness

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: IBU TID; Drug: IBU BID; Drug: Placebo TID; Drug: Placebo BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01794923

B3491010

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

205 participants in 4 patient groups, including a placebo group

Ibuprofen 5% topical gel BID

Experimental group

Description:

IBU BID (Treatment A)

Treatment:

Drug: IBU BID

Placebo topical gel BID

Placebo Comparator group

Description:

Placebo BID (Treatment B)

Treatment:

Drug: Placebo BID

Ibuprofen 5% topical gel TID

Experimental group

Description:

IBU TID (Treatment C)

Treatment:

Drug: IBU TID

Placebo topical gel TID

Placebo Comparator group

Description:

Placebo TID (Treatment D)

Treatment:

Drug: Placebo TID