CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 205 enrolled
Drug / intervention
IBU BID +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01794923
NCT01794923Phase 3Completed
CompareCT.gov

PLACEBO-CONTROLLED, DOUBLE-BLIND EVALUATION OF THE EFFICACY AND SAFETY OF IBUPROFEN 5% TOPICAL GEL FOR THE TREATMENT OF DELAYED-ONSET MUSCLE SORENESS OF THE ELBOW FLEXOR MUSCLES

Pfizer·interventional·Posted Feb 20, 2013·Updated Sep 30, 2021

In Brief

A Phase 3 clinical trial evaluating IBU BID, Placebo BID, and 2 other interventions for Pain. Completed, enrolled 205 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2013
Enrollment StartJun 13, 2013
Primary CompletionMar 29, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.4 years ago

Interventions

IBU BIDdrug

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

Placebo BIDdrug

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

IBU TIDdrug

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

Placebo TIDdrug

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