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

Sponsor:	Purdue Pharma LP
Information provided by:	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 delivery systems Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

The 'average pain over the last 24 hours' scores at week 12 of the double-blind phase. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The daily number of tablets of nonopioid supplemental analgesic medications taken during weeks 2 through 12 of the double-blind phase and the Sleep Disturbance Subscale of the Medical Outcome Study (MOS) Sleep Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	520
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
1: Experimental Buprenorphine transdermal delivery system 10 and 20 worn for 7 days	Drug: buprenorphine transdermal delivery systems transdermal delivery system 10 and 20 worn for 7 days
2: Placebo Comparator	Drug: Placebo transdermal delivery 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

No publications provided

Responsible Party:	Purdue Pharma L.P. ( Medical Monitor )
Study ID Numbers:	BUP3024
Study First Received:	June 21, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00490919 History of Changes
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:

Narcotic Antagonists
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Low Back Pain
Narcotics
Pain
Back Pain
Pharmacologic Actions

Signs and Symptoms
Buprenorphine
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 05, 2009