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

April 11, 2008 updated by: Mundipharma K.K.

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Osteoarthritic Pain of the Hip or Knee

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe osteoarthritic pain of the hip or knee who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan
        • Investigational Site
      • Osaka, Japan
        • Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Investigational Site
      • Okazaki, Aichi, Japan
        • Investigational Site
    • Chiba
      • Ichikawa, Chiba, Japan
        • Investigational Site
      • Matsudo, Chiba, Japan
        • Investigational Site
      • Nagareyama, Chiba, Japan
        • Investigational Site
    • Gunma
      • Annaka, Gunma, Japan
        • Investigational Site
      • Takasaki, Gunma, Japan
        • Investigational Site
    • Hokkaido
      • Chitose, Hokkaido, Japan
        • Investigational Site
      • Sapporo, Hokkaido, Japan
        • Investigational Site
    • Hyogo
      • Kako, Hyogo, Japan
        • Investigational Site
      • Kobe, Hyogo, Japan
        • Investigational Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Investigational Site
    • Kyoto
      • Joyo, Kyoto, Japan
        • Investigational Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Investigational Site
    • Nagasaki
      • Isahaya, Nagasaki, Japan
        • Investigational Site
    • Saitama
      • Kasukabe, Saitama, Japan
        • Investigational Site
      • Koshigaya, Saitama, Japan
        • Investigational Site
    • Shiga
      • Hikone, Shiga, Japan
        • Investigational Site
    • Tokyo
      • Adachi, Tokyo, Japan
        • Investigational Site
      • Arakawa, Tokyo, Japan
        • Investigational Site
      • Edogawa, Tokyo, Japan
        • Investigational Site
      • Koto, Tokyo, Japan
        • Investigational Site
      • Setagaya, Tokyo, Japan
        • Investigational Site
      • Suginami, Tokyo, Japan
        • Investigational Site
    • Toyama
      • Himi, Toyama, Japan
        • Investigational Site
      • Kurobe, Toyama, Japan
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females ages 40 years or older.
  • Clinical diagnosis of osteoarthritis (OA) of the hip or knee.

Exclusion Criteria:

  • Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, and diabetic neuropathy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Buprenorphine Transdermal System
Buprenorphine Transdermal System 5, 10 or 20mg/patch is applied for 12weeks
Placebo Comparator
Drug: Placebo
Corresponding placebo is applied for 12weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time to the development of inadequate analgesia
Time Frame: Up to 12weeks
Up to 12weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
Time Frame: 12weeks
12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma K.K.

Investigators

  • Study Chair: Mutsukuni Kataoka, Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 11, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUP3801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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