Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312572
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2006-04-07
Brief Title:
Safety and Efficacy of Dose Conversion From Vicodin to Buprenorphine Transdermal System Butrans in Subjects With OA Pain
Sponsor:
Purdue Pharma LP
Organization:
Purdue Pharma LP
Study Overview
Official Title:
A Randomized Double-Blind Study Evaluating the Dose Conversion From Vicodin to Buprenorphine Transdermal System BTDS in Subjects With Osteoarthritis OA Pain
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Buprenorphine is a synthetic opioid analgesic with over 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None