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Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain

NCT00346047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2008-04-15

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.

Conditions

  • Low Back Pain

Interventions

DRUG

Placebo

Corresponding placebo is applied for 12weeks

DRUG

Buprenorphine Transdermal System

Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks

Sponsors & Collaborators

  • Mundipharma K.K.

    lead INDUSTRY

Principal Investigators

  • Mutsukuni Kataoka · Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT00346047 on ClinicalTrials.gov