Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320801
Status:
TERMINATED
Last Update Posted:
2012-09-03
First Post:
2006-04-28
Brief Title:
Buprenorphine Transdermal Patches BTDS in Subjects With Osteoarthritis Pain Includes a 52-week Extension Phase
Sponsor:
Purdue Pharma LP
Organization:
Purdue Pharma LP
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain Includes a 52-Week Extension Phase
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated early due to administrative reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system BTDS 20 micrograms mcghour h in comparison to the buprenorphine transdermal system 5 mcgh in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication acetaminophen or ibuprofen will be provided to all subjects in addition to study drug
This study was terminated early due to administrative reasons with only 20 of the planned sample size therefore the primary objective was changed to focus on the safety evaluation
This study was terminated early due to administrative reasons with only 20 of the planned sample size therefore the primary objective was changed to focus on the safety evaluation
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