A Phase 3 interventional study of Buprenorphine transdermal system and Placebo in Low Back Pain, sponsored by Purdue Pharma LP. Completed at 86 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-10.
Sponsored by Purdue Pharma LP · Phase 3, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 539 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
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Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal system
Placebo transdermal system to match BTDS patches, applied for 7 days
Drug: Placebo
Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days
Also known as: Butrans™
transdermal system (placebo) worn for 7 days
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
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.
The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase
Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.
Time frame: weeks 2-12
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
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.
Time frame: Weeks 4, 8, 12 of double-blind phase
Study dates: 27-Jun-2007 (first patient first visit) to 24-Jul-2008 (last patient last visit), at 86 medical/research sites in the USA.
| Milestone | Open-label Run-in Period | Double-blind BTDS 10 or 20 | Double-blind Placebo TDS |
|---|---|---|---|
| Started | 1024 | 0 | 0 |
| Completed | 541 | 0 | 0 |
| Not completed | 483 | 0 | 0 |
| Withdrew: Adverse event | 239 | 0 | 0 |
| Withdrew: Withdrawal by subject | 37 | 0 | 0 |
| Withdrew: Lost to follow-up | 21 | 0 | 0 |
| Withdrew: Lack of efficacy | 143 | 0 | 0 |
| Withdrew: Administrative | 40 | 0 | 0 |
| Withdrew: Confirmed or suspected diversion | 3 | 0 | 0 |
| Milestone | Open-label Run-in Period | Double-blind BTDS 10 or 20 | Double-blind Placebo TDS |
|---|---|---|---|
| Started | 0 | 256 | 283 |
| Completed | 0 | 170 | 199 |
| Not completed | 0 | 86 | 84 |
| Withdrew: Adverse event | 0 | 40 | 20 |
| Withdrew: Withdrawal by subject | 0 | 10 | 11 |
| Withdrew: Lost to follow-up | 0 | 8 | 11 |
| Withdrew: Lack of efficacy | 0 | 22 | 36 |
| Withdrew: Administrative | 0 | 6 | 6 |
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
| Units on a scale | Double-blind BTDS | Double-blind Placebo TDS |
|---|---|---|
| Screening | 7.24 ± 1.263 | 7.17 ± 1.223 |
| Prerandomization | 2.57 ± 1.283 | 2.56 ± 1.207 |
| Week 12 - Primary outcome | 3.83 ± 2.738 | 4.38 ± 2.690 |
Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.
| tablets | Double-blind BTDS | Double-blind Placebo TDS |
|---|---|---|
| The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase | 0.620 ± 0.0658 | 0.743 ± 0.0574 |
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.
| Units on a scale | Double-blind BTDS | Double-blind Placebo TDS |
|---|---|---|
| Week 4 | 32.84 ± 25.552 | 41.20 ± 26.813 |
| Week 8 | 35.63 ± 26.276 | 39.87 ± 26.362 |
| Week 12 | 34.97 ± 26.871 | 40.42 ± 26.675 |
Collected over Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.. Non-serious events are listed at a 4.50% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double-blind BTDS 10, 20 | — | 3/256 (1.2%) | 52/256 (20.3%) |
| Double-blind Placebo TDS 10, 20 | — | 2/283 (0.7%) | 63/283 (22.3%) |
| Open-label Run-in Period, BTDS 5, 10, 20 | — | 4/1,024 (0.4%) | 437/1,024 (42.7%) |
| Event | Double-blind BTDS 10, 20 | Double-blind Placebo TDS 10, 20 | Open-label Run-in Period, BTDS 5, 10, 20 |
|---|---|---|---|
| Road traffic accidentInjury, poisoning and procedural complications | 1/256 | 0/283 | 1/1024 |
| Major depressionPsychiatric disorders | 1/256 | 0/283 | 0/1024 |
| Drug abuserSocial circumstances | 1/256 | 0/283 | 0/1024 |
| Acute myocardial infarctionCardiac disorders | 0/256 | 1/283 | 0/1024 |
| Homicidal thoughtsPsychiatric disorders | 0/256 | 1/283 | 0/1024 |
| AnxietyPsychiatric disorders | 0/256 | 1/283 | 0/1024 |
| Suicidal ideationPsychiatric disorders | 0/256 | 1/283 | 0/1024 |
| VomitingGastrointestinal disorders | 0/256 | 0/283 | 1/1024 |
| Skin lacerationInjury, poisoning and procedural complications | 0/256 | 0/283 | 1/1024 |
| Joint sprainInjury, poisoning and procedural complications | 0/256 | 0/283 | 1/1024 |
| Event | Double-blind BTDS 10, 20 | Double-blind Placebo TDS 10, 20 | Open-label Run-in Period, BTDS 5, 10, 20 |
|---|---|---|---|
| NauseaGastrointestinal disorders | 32/256 | 31/283 | 240/1024 |
| DizzinessNervous system disorders | 10/256 | 3/283 | 102/1024 |
| HeadacheNervous system disorders | 14/256 | 14/283 | 100/1024 |
| Application site pruritusGeneral disorders | 11/256 | 19/283 | 87/1024 |
| SomnolenceNervous system disorders | 4/256 | 6/283 | 84/1024 |
| VomitingGastrointestinal disorders | 11/256 | 5/283 | 77/1024 |
| ConstipationGastrointestinal disorders | 9/256 | 3/283 | 67/1024 |
| Application site erythemaGeneral disorders | 9/256 | 14/283 | 32/1024 |
| Application site rashGeneral disorders | 12/256 | 7/283 | 18/1024 |
| Age Continuous(years) | Double-blind BTDS | Double-blind Placebo TDS | Total |
|---|---|---|---|
| Mean | 48.9 ± 12.50 | 50.1 ± 13.31 | 49.5 ± 12.93 |
| Sex: Female, Male(Participants) | Double-blind BTDS | Double-blind Placebo TDS | Total |
|---|---|---|---|
| Female | 133 | 163 | 296 |
| Male | 123 | 120 | 243 |
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Purdue Pharma LP