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Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain

NCT01054820 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2012-08-16

Study results available
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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.

Conditions

  • Acute Back Strain

Interventions

DRUG

FLECTOR® Patch (diclofenac epolamine topical patch) 1.3%

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-03-31
Completion
2010-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054820 on ClinicalTrials.gov