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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
660
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
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)
Time frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Mean Daily Number of Supplemental Analgesic Tablets
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Time frame: 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.)
Time frame: 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.
Time frame: Weeks 4, 8, 12 of the double-blind phase
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