CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 123 enrolled
Drug / intervention
FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%drug
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/NCT01054820
NCT01054820Phase 4Completed
CompareCT.gov

Multicenter, Open-Label Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

Pfizer·interventional·Posted Jan 22, 2010·Updated Aug 16, 2012

In Brief

A Phase 4 clinical trial evaluating FLECTOR® Patch (diclofenac epolamine topical patch) 1.3% for Acute Back Strain. Completed, enrolled 123 participants.

Detailed Summary

Although approved for minor strains, sprains and contusions, FLECTOR Patch has not been studied extensively in the setting of acute back strain. This study is being conducted as an initial step in demonstrating the benefit of FLECTOR Patch specifically for back strain. In particular, this study is expected to provide information about the amount of improvement in back strain among subjects using the FLECTOR Patch, which may then be used to inform subsequent studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Back Strain
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2010
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.4 years ago

Interventions

FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%drug

One FLECTOR Patch applied to the most painful area on the subject's back every 12 hours for up to 14 days.