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NCT01141283

Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Last Updated: 2012-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-07-31

Brief Summary

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The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Detailed Description

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Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Conditions

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Osteoarthritis

Keywords

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Osteoarthritis Opioid Transdermal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BTDS

Buprenorphine transdermal patch

Group Type EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type DRUG

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Buprenorphine transdermal patch

Intervention Type DRUG

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

Buprenorphine transdermal patch

Intervention Type DRUG

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Interventions

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Buprenorphine transdermal patch

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Intervention Type DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

Intervention Type DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria

* Excluded from the study are subjects who ingest \> 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
* Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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BUP3012S

Identifier Type: -

Identifier Source: org_study_id

Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

BTDS

Buprenorphine transdermal patch

Buprenorphine transdermal patch

Buprenorphine transdermal patch

Interventions

Buprenorphine transdermal patch

Buprenorphine transdermal patch

Buprenorphine transdermal patch

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Purdue Pharma LP

Responsible Party

Locations

Vista Medical Research Inc.

Arthrocare, Arthritis Care and Research

Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research

Arizona Research Center

Research Facility

Advanced Pain Medicine

Orange County Clinical Research

San Diego Arthritis & Osteoporosis Medical Clinic

Research Facility

Research Facility

Research Facility

Research Facility

Research Facility

Research Facility

Allergy, Asthma, Arthritis & Lung

University Clinical Research Deland

Research Facility

Coastal Medical Research

Research Facility

Research Facility

Research Facility

Research Facility

Research Facility

Primary Care Medical Center

Great Lakes Family Care

Research Facility

Beth Israel/Dept. of Pain

Research Facility

Research Facility

Altoona Center for Clinical Research

University Orthopedics & Sport Medicine Center

Research Facility

Low Country Rheumatology, PA

Central Plains Clin-Brown Site

Research Facility

Research Facility

Research Facility

Research Facility

Granger Medical Clinic

Hilltop Medical Center

Research Facility

Internal Medicine Northwest

Countries

Other Identifiers

BUP3012S