Back to resultsSafety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal delivery system
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, opioid, transdermal
Eligibility 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.
Sites / Locations
- Park Place Therapeutic Center
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
pain intensity
acceptability of therapy
quality of sleep
rescue dose usage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00315835
Brief Title
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
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 Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1997 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Purdue Pharma LP
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, opioid, transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal delivery system
Primary Outcome Measure Information:
Title
clinical laboratory tests
Title
vital signs
Title
physical examinations
Title
electrocardiograms
Title
elicited opioid side effects
Title
pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
Title
adverse events
Title
application site skin observations
Title
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 Measure Information:
Title
pain intensity
Title
acceptability of therapy
Title
quality of sleep
Title
rescue dose usage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Park Place Therapeutic Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
12. IPD Sharing Statement
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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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