Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
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Purpose
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Drug: Buprenorphine transdermal delivery system |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Single Dose, Randomized, Double-Blind, Parallel Group Study of the Safety and Pharmacokinetics of Buprenorphine TDS (12.5, 25, 50 Mcg/Hour) Vs. Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery |
- clinical laboratory tests
- vital signs
- physical examinations
- electrocardiograms
- elicited opioid side effects
- pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
- adverse events
- application site skin observations
- plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination
- pain intensity
- acceptability of therapy
- quality of sleep
- rescue dose usage
| Estimated Enrollment: | 100 |
| Study Start Date: | October 1996 |
| Estimated Study Completion Date: | November 1997 |
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized >/=4 days postoperatively.
- in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for >/=4 days post-surgery.
Exclusion Criteria:
- receiving chronic opioid therapy preoperatively for >1 month that was at a total daily dose of >/= 60 mg of oral morphine equivalents.
- have significant concurrent pulmonary conditions.
Other protocol-specific exclusion/inclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00315835 History of Changes |
| Other Study ID Numbers: | BP96-0104 |
| Study First Received: | April 17, 2006 |
| Last Updated: | April 17, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
postoperative pain opioid transdermal |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013