CLINICAL TRIALS PROFILE FOR BUTRANS
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All Clinical Trials for BUTRANS
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00312572 ↗ | Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain | Completed | Purdue Pharma LP | Phase 3 | 2003-06-01 | The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed. |
NCT00403234 ↗ | Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement | Terminated | Purdue Pharma LP | Phase 2 | 2006-11-01 | The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug. Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations. |
NCT01324570 ↗ | Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children | Completed | Purdue Pharma LP | Phase 3 | 2011-07-01 | The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years. |
NCT01999114 ↗ | The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers | Completed | Purdue Pharma LP | Phase 1 | 2012-03-01 | The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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