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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Back Pain Lower Back Chronic

Intervention / Treatment
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* Drug: Buprenorphine
* Drug: Buprenorphine
* Drug: Oxycodone Immediate-Release


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BTDS 5<br>Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear. | Drug: Buprenorphine<br>* Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.<br>* Other names: Butrans™;|
| Experimental: BTDS 20<br>Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. | Drug: Buprenorphine<br>* Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear<br>* Other names: Butrans™;|
| Experimental: Oxycodone Immediate-Release<br>Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). | Drug: Oxycodone Immediate-Release<br>* Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | 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) | Last 24 hours score at weeks 4, 8, 12 of the double-blind phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily Number of Supplemental Analgesic Tablets | The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase | Double-blind phase (84 days) | 
| Oswestry Disability Index (ODI) Score (V 2.0) | 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.) | Weeks 4, 8, 12 | 
| The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. | 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. | Weeks 4, 8, 12 of the double-blind phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, opioid, transdermal, Butrans