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

Phase 3

Completed

• Conditions: Pain; Osteoarthritis
• Interventions: Drug: Placebo; Drug: Buprenorphine Transdermal System

• Registration Number: NCT00345787
• Lead Sponsor: Mundipharma K.K.

Brief 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 osteoarthritic pain of the hip or knee.

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-29
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-11
• Last Update Posted: 2008-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0	Placebo	-
1	Buprenorphine Transdermal System	-

Primary Outcome Measures

Name	Time	Method
The time to the development of inadequate analgesia	Up to 12weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores	12weeks

Trial Locations

Locations (1)

Investigational Site; 🇯🇵 Osaka, Japan