- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315835
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
April 17, 2006 updated by: Purdue Pharma LP
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Plantation, Florida, United States, 33324
- Park Place Therapeutic Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
adverse events
|
vital signs
|
physical examinations
|
clinical laboratory tests
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electrocardiograms
|
elicited opioid side effects
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pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia)
|
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
Outcome Measure |
---|
pain intensity
|
quality of sleep
|
acceptability of therapy
|
rescue dose usage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1996
Study Completion
November 1, 1997
Study Registration Dates
First Submitted
April 17, 2006
First Submitted That Met QC Criteria
April 17, 2006
First Posted (Estimate)
April 19, 2006
Study Record Updates
Last Update Posted (Estimate)
April 19, 2006
Last Update Submitted That Met QC Criteria
April 17, 2006
Last Verified
April 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP96-0104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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