Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain - Full Text View

Sponsor:	Purdue Pharma LP
Information provided by (Responsible Party):	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00313014

Purpose

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Condition	Intervention	Phase
Chronic Low Back Pain	Drug: Buprenorphine Drug: Oxycodone Immediate-Release	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. [ Time Frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase ] [ Designated as safety issue: No ]
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)

Secondary Outcome Measures:

Mean Daily Number of Supplemental Analgesic Tablets [ Time Frame: Double-blind phase (84 days) ] [ Designated as safety issue: No ]
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Oswestry Disability Index (ODI) Score (V 2.0) [ Time Frame: Weeks 4, 8, 12 ] [ Designated as safety issue: No ]
The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.

The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. [ Time Frame: Weeks 4, 8, 12 of the double-blind phase ] [ Designated as safety issue: No ]
The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).

Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

Enrollment:	660
Study Start Date:	February 2004
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: BTDS 5 Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.	Drug: Buprenorphine Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. Other Name: Butrans™
Experimental: BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.	Drug: Buprenorphine Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear Other Name: Butrans™
Experimental: Oxycodone Immediate-Release Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	Drug: Oxycodone Immediate-Release Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

low back pain for 3 months or longer, confirmed by radiographic evidence.
receiving a stable dose of an opioid analgesic for low back pain.

Exclusion Criteria:

taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313014

Show 85 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

Investigators

Principal Investigator:

Martin Hale, MD

Gold Coast Research LLC, Weston, FL, USA

More Information

Additional Information:

Product Information This link exits the ClinicalTrials.gov site

Publications:

Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and Safety of Buprenorphine Transdermal System (BTDS) for Chronic Moderate to Severe Low Back Pain: A Randomized, Double-Blind Study. J Pain. 2011 Jul 30; [Epub ahead of print]

Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00313014 History of Changes
Other Study ID Numbers:	BUP3015
Study First Received:	April 10, 2006
Results First Received:	July 28, 2010
Last Updated:	November 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Low back pain
opioid
transdermal
Butrans

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Buprenorphine
Oxycodone
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on February 13, 2012