A Phase 3 interventional study of Buprenorphine transdermal patch and Buprenorphine transdermal patch in Back Pain Lower Back Chronic, sponsored by Purdue Pharma LP. Terminated at 84 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-03.
Sponsored by Purdue Pharma LP · Phase 3, Interventional, and Treatment
The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose [up to BTDS 20 micrograms (mcg) / hour (h)] depending on adequate pain relief and tolerability.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 354 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Also known as: Butrans™
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Also known as: Butrans™
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Also known as: Butrans™
Number of Participants With Adverse Events (AEs) as a Measure of Safety
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
Time frame: 52-week extension phase
Study dates: 17-Jun-2004 to 23-Sep-2005 at 52 medical/research sites in the United States participated in the extension study.
| Milestone | Total BTDS 5, 10, 20 |
|---|---|
| Started | 354 |
| Completed | 15 |
| Not completed | 339 |
| Withdrew: Adverse event | 43 |
| Withdrew: Lost to follow-up | 23 |
| Withdrew: Withdrawal by subject | 31 |
| Withdrew: Administrative | 223 |
| Withdrew: Lack of efficacy | 19 |
The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).
| participants | Total BTDS 5, 10, 20 |
|---|---|
| Death | 1 |
| Serious adverse events | 20 |
| All other adverse events in ≥ 4.5% of subjects | 153 |
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 or sequelae resolved.. Non-serious events are listed at a 4.50% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total BTDS 5, 10, 20 | — | 20/354 (5.6%) | 153/354 (43.2%) |
| Event | Total BTDS 5, 10, 20 |
|---|---|
| Chest painGeneral disorders | 2/354 |
| DehydrationMetabolism and nutrition disorders | 2/354 |
| Acute coronary syndromeCardiac disorders | 1/354 |
| Myocardial infarctionCardiac disorders | 1/354 |
| Abdominal herniaGastrointestinal disorders | 1/354 |
| NauseaGastrointestinal disorders | 1/354 |
| Intractable nauseaGastrointestinal disorders | 1/354 |
| Intractable vomitingGastrointestinal disorders | 1/354 |
| Right inguinal herniaGastrointestinal disorders | 1/354 |
| VomitingGastrointestinal disorders | 1/354 |
| Event | Total BTDS 5, 10, 20 |
|---|---|
| HeadacheNervous system disorders | 55/354 |
| Application site pruritusGeneral disorders | 37/354 |
| Application site erythemaGeneral disorders | 36/354 |
| NauseaGastrointestinal disorders | 34/354 |
| Application site rashGeneral disorders | 32/354 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 27/354 |
| Back pain aggravatedMusculoskeletal and connective tissue disorders | 16/354 |
| Age Continuous(years) | Total BTDS 5, 10, 20 |
|---|---|
| Mean | 51.2 ± 12.47 |
| Sex: Female, Male(Participants) | Total BTDS 5, 10, 20 |
|---|---|
| Female | 157 |
| Male | 197 |
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Purdue Pharma LP