Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

Sponsor

Purdue Pharma LP (Industry)

Overall Status

Completed

CT.gov ID

NCT00314652

Collaborator

(none)

260

Enrollment

Locations

Duration (Months)

11.8

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Buprenorphine transdermal delivery system	Phase 3

Detailed Description

Buprenorphine is a synthetic opioid analgesic with over twenty-five 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee

Study Start Date :

Jun 1, 1999

Study Completion Date :

Oct 1, 1999

Outcome Measures

Primary Outcome Measures

Percentage of patients who were treated successfully for pain management []
a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit []

Secondary Outcome Measures

Average pain intensity and patient satisfaction scores []
Incidence of early discontinuation due to lack of efficacy []
Time to early discontinuation due to lack of efficacy []
Dose level at end of titration []
Investigator's assessment of therapeutic response []
Diary pain scores []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

Exclusion Criteria:

receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hawthorne & York, International, Ltd.	Phoenix	Arizona	United States	85008
2	Arizona Research Center, LLC	Phoenix	Arizona	United States	85023
3	ACRC/Arizona Clinical Research	Tucson	Arizona	United States	85712
4	Advanced Clinical Therapeutics	Tucson	Arizona	United States	85712
5	San Diego Arthritis and Osteoporosis Research	San Diego	California	United States	92120
6	Scripps Clinic Rancho Bernardo	San Diego	California	United States	92128
7	Clinical Research Consultants, Inc.	Trumbull	Connecticut	United States	06611
8	Tampa Bay Medical Research, Inc.	Clearwater	Florida	United States	33761
9	University Clinical Research	Deland	Florida	United States	32720
10	Gainesville Clinical Research Center	Gainesville	Florida	United States	32605
11	Physicians Research Associates Jacksonville	Jacksonville	Florida	United States	32216
12	University Clinical Research, Inc.	Pembroke Pines	Florida	United States	33024
13	Gold Coast Research, Inc.	Weston	Florida	United States	33331
14	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
15	Westside Family Medical Center	Kalamazoo	Michigan	United States	49009
16	Center for Pharmaceutical Research	Kansas City	Missouri	United States	64114
17	NJP Clinical Research	Passaic	New Jersey	United States	07055
18	PW Clinical Research, LLC	Winston-Salem	North Carolina	United States	27103
19	New Century Research Center, Ltd.	Beaverbrook	Ohio	United States	45431
20	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
21	Mid-South Clinical Research Institute	Memphis	Tennessee	United States	38120
22	Advanced Clinical Research	Salt Lake City	Utah	United States	84102