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Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.

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ClinicalTrials.gov Identifier: NCT00315835
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : April 19, 2006
Sponsor:
Information provided by:
Purdue Pharma LP

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Drug: Buprenorphine transdermal delivery system Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 1996
Study Completion Date : November 1997

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Primary Outcome Measures :
  1. clinical laboratory tests
  2. vital signs
  3. physical examinations
  4. electrocardiograms
  5. elicited opioid side effects
  6. pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
  7. adverse events
  8. application site skin observations
  9. plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination

Secondary Outcome Measures :
  1. pain intensity
  2. acceptability of therapy
  3. quality of sleep
  4. rescue dose usage


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315835


Locations
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United States, Florida
Park Place Therapeutic Center
Plantation, Florida, United States, 33324
Sponsors and Collaborators
Purdue Pharma LP

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ClinicalTrials.gov Identifier: NCT00315835     History of Changes
Other Study ID Numbers: BP96-0104
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: April 19, 2006
Last Verified: April 2006

Keywords provided by Purdue Pharma LP:
postoperative pain
opioid
transdermal

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists