Conditions: Pain
Keywords: Delayed onset muscle soreness ibuprofen topical
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 205
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: IBU BID (Treatment A) arm 2: Placebo BID (Treatment B) arm 3: IBU TID (Treatment C) arm 4: Placebo TID (Treatment D)

Interventions: intervention 1: IBU BID intervention 2: Placebo BID intervention 3: IBU TID intervention 4: Placebo TID
Intervention descriptions: intervention 1: 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days intervention 2: 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days intervention 3: 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days intervention 4: 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days

Protocol document: