Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain - Full Text View

Sponsor:	Purdue Pharma LP
Information provided by (Responsible Party):	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00490919

Purpose

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Condition	Intervention	Phase
Low Back Pain	Drug: Buprenorphine transdermal system Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. [ Time Frame: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase. ] [ Designated as safety issue: No ]
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.

Secondary Outcome Measures:

The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase [ Time Frame: weeks 2-12 ] [ Designated as safety issue: No ]
Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: Weeks 4, 8, 12 of 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 of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 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:	539
Study Start Date:	June 2007
Study Completion Date:	October 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Double-blind BTDS 10 or 20 Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear	Drug: Buprenorphine transdermal system Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days Other Name: Butrans™
Placebo Comparator: Double-blind Placebo TDS Placebo transdermal system to match BTDS patches, applied for 7 days	Drug: Placebo transdermal system (placebo) worn for 7 days

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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day,
Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

Exclusion Criteria:

Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490919

Show 86 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

Additional Information:

Product Information This link exits the ClinicalTrials.gov site

Publications:

Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and Safety of the Seven-Day Buprenorphine Transdermal System in Opioid-Naïve Patients with Moderate to Severe Chronic Low Back Pain: An Enriched, Randomized, Double-Blind, Placebo-Controlled Study. J Pain Symptom Manage. 2011 Sep 23; [Epub ahead of print]

Responsible Party:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00490919 History of Changes
Other Study ID Numbers:	BUP3024
Study First Received:	June 21, 2007
Results First Received:	July 15, 2010
Last Updated:	October 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Chronic pain
opioid
transdermal
Moderate to severe chronic low back pain

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Buprenorphine
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