Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108771
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-04-18
Brief Title:
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic Moderate to Severe Osteoarthritis OA Pain
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
Double-Blind Parallel Randomized Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic Moderate to Severe Osteoarthritis OA Pain
Status:
COMPLETED
Status Verified Date:
2012-06
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 purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief
Detailed Description:
This study will evaluate the analgesic efficacy of the matrix fentanyl patch The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis OA pain This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs Nonsteroidal Anti-inflammatory Drugs or acetaminophen or who have received intermittent opioid analgesic treatment
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