A Phase 3 interventional study of Buprenorphine transdermal patch and Placebo to match BTDS in Chronic Non-malignant Pain, sponsored by Purdue Pharma LP. Completed at 42 sites in 2 countries. 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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) 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.
Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Placebo to match buprenorphine transdermal patch
Drug: Placebo to match BTDS
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Also known as: Butrans™
Placebo to match buprenorphine transdermal patch applied for 7-day wear.
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Ineffective treatment was defined as: * Subject took \>1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
Time frame: Double-blind phase (14 days)
Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
The time of ineffective treatment was calculated as the earliest of the following: * The date the subject first took \>1 gram of acetaminophen, * The visit date when ineffective treatment was first determined, or * The date the last patch was removed.
Time frame: 14 days
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
Time frame: 14 days
The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
Time frame: 14 days
(First patient first visit) 19-Mar-2001 to (last patient last visit) 22-Jul-2001 at 42 centers: 21 in the UK and 21 in the US.
| Milestone | Double-blind Placebo Patch | Double-blind BTDS |
|---|---|---|
| Started | 138 | 129 |
| Completed | 132 | 123 |
| Not completed | 6 | 6 |
| Withdrew: Adverse event | 4 | 6 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
Ineffective treatment was defined as: * Subject took \>1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
| participants | Double-blind Placebo Patch | Double-blind BTDS | Total |
|---|---|---|---|
| Subjects With Ineffective Treatment | 89 | 66 | 155 |
| Reason: took more than 1 gram of acetaminophen/day | 81 | 59 | 140 |
| Reason: required a change in TDS dose | 34 | 25 | 59 |
| Reason: difficulty keeping patch on | 6 | 1 | 7 |
| Reason: discontinued due to ineffective treatment | 2 | 3 | 5 |
The time of ineffective treatment was calculated as the earliest of the following: * The date the subject first took \>1 gram of acetaminophen, * The visit date when ineffective treatment was first determined, or * The date the last patch was removed.
| Days | Double-blind Placebo Patch | Double-blind BTDS |
|---|---|---|
| Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment | 5.6 ± 0.44 | 7.4 ± 0.45 |
Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
| participants | Double-blind Placebo Patch | Double-blind BTDS |
|---|---|---|
| Subjects w/ineffective treatment or who discont'd | 93 | 71 |
| Ineffective Treatment | 89 | 66 |
| Discontinued due to other reasons | 5 | 6 |
The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
| Tablets | Double-blind Placebo Patch | Double-blind BTDS |
|---|---|---|
| The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). | 2.2 ± 0.15 | 1.8 ± 0.14 |
Collected over Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.. Non-serious events are listed at a 4.50% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double-blind Placebo Patch | — | 0/138 (0%) | 21/138 (15.2%) |
| Double-blind BTDS | — | 0/129 (0%) | 25/129 (19.4%) |
| Open-label Run-in Period BTDS 5, 10 or 20 | — | 7/588 (1.2%) | 245/588 (41.7%) |
| Event | Double-blind Placebo Patch | Double-blind BTDS | Open-label Run-in Period BTDS 5, 10 or 20 |
|---|---|---|---|
| DehydrationMetabolism and nutrition disorders | 0/138 | 0/129 | 2/588 |
| Pain abdominalGeneral disorders | 0/138 | 0/129 | 1/588 |
| AbscessGeneral disorders | 0/138 | 0/129 | 1/588 |
| Injury accidentalGeneral disorders | 0/138 | 0/129 | 1/588 |
| CellulitisGeneral disorders | 0/138 | 0/129 | 1/588 |
| Pain, chestGeneral disorders | 0/138 | 0/129 | 1/588 |
| Fibrillation, atrialCardiac disorders | 0/138 | 0/129 | 1/588 |
| GastroenteritisImmune system disorders | 0/138 | 0/129 | 1/588 |
| DepressionNervous system disorders | 0/138 | 0/129 | 1/588 |
| Event | Double-blind Placebo Patch | Double-blind BTDS | Open-label Run-in Period BTDS 5, 10 or 20 |
|---|---|---|---|
| NauseaGastrointestinal disorders | 5/138 | 4/129 | 112/588 |
| Erythema at siteSkin and subcutaneous tissue disorders | 18/138 | 17/129 | 43/588 |
| DizzinessNervous system disorders | 0/138 | 0/129 | 73/588 |
| Pruritus at siteSkin and subcutaneous tissue disorders | 7/138 | 12/129 | 58/588 |
| HeadacheGeneral disorders | 3/138 | 5/129 | 44/588 |
| SomnolenceNervous system disorders | 1/138 | 3/129 | 41/588 |
| AstheniaGeneral disorders | 3/138 | 2/129 | 36/588 |
| VomitGastrointestinal disorders | 0/138 | 1/129 | 36/588 |
| Age Continuous(years) | Double-blind Placebo Patch | Double-blind BTDS | Total |
|---|---|---|---|
| Mean | 59.2 ± 11.48 | 56.2 ± 13.34 | 57.7 ± 12.48 |
| Sex: Female, Male(Participants) | Double-blind Placebo Patch | Double-blind BTDS | Total |
|---|---|---|---|
| Female | 88 | 79 | 167 |
| Male | 50 | 50 | 100 |
| Region of Enrollment(participants) | Double-blind Placebo Patch | Double-blind BTDS | Total |
|---|---|---|---|
| United States | 46 | 42 | 88 |
| United Kingdom | 92 | 87 | 179 |
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Purdue Pharma LP