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Flurbiprofen Tape for Treatment of Chronic Low Back Pain

NCT00759330 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2016-10-06

Study results available
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Summary

The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).

Conditions

  • Chronic Low Back Pain

Interventions

DRUG

Placebo Tape (Arm 1)

Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.

DRUG

Flurbiprofen Tape (Arm 2)

Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.

DRUG

Placebo Tape (Arm 3)

Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.

DRUG

Flurbiprofen Tape (Arm 4)

Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.

Sponsors & Collaborators

  • Teikoku Pharma USA, Inc.

    lead INDUSTRY

Principal Investigators

  • James Song · Teikoku Pharma USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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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 NCT00759330 on ClinicalTrials.gov