Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
This study has been completed.
Sponsor:
Purdue Pharma LP
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00490919
First received: June 21, 2007
Last updated: September 5, 2012
Last verified: September 2012
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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 3 |
| 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:
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
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Purdue Pharma LP
More Information
Additional Information:
Publications:
| 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: | September 5, 2012 |
| 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 May 16, 2013