The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.

Back Pain Clinical Trial

Official title:

Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315874
• Other study ID #: BP96-0102
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2006
• Last updated: May 13, 2013
• Start date: April 1997
• Est. completion date: January 1998

Study information

• Verified date: May 2013
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.

• taking >/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

• receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.

• scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Buprenorphine transdermal delivery system

Locations

Country	Name	City	State
United States	Atlanta Research Center	Atlanta	Georgia
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Gainesville Clinical Research Center	Gainesville	Florida
United States	Rheumatology Associates, Inc.	Indianapolis	Indiana
United States	Westside Family Medical Center	Kalamazoo	Michigan
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	The New York Hospital Cornell Medical Center	New York	New York
United States	Arizona Research & Education	Phoenix	Arizona
United States	Hawthorne & York, Intl, Ltd	Phoenix	Arizona
United States	Park Place Therapeutic Center	Plantation	Florida
United States	NC Clinical Research, Inc.	Raleigh	North Carolina
United States	Pain Control Ctr Bowman Gray School of Med	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination.
Secondary	Brief Pain Inventory
Secondary	dropouts due to lack of efficacy
Secondary	MOS health survey
Secondary	VAS pain intensity
Secondary	therapeutic response
Secondary	patient preference
Secondary	daily patient diary
Secondary	and number of oxycodone/acetaminophen or placebo tablets taken