Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420992
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2007-01-10
Brief Title:
A Study of Embeda Kadian NT ALO-01 in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Efficacy Study of Kadian NT Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee
Status:
COMPLETED
Status Verified Date:
2013-09
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 efficacy of Kadian NT ALO-01 compared with placebo for treating moderate to severe chronic pain over a 12 week period
Detailed Description:
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain focusing on osteoarthritis of the hip or knee as measured by mean change in diary Brief Pain Inventory BPI score of average pain daily scores of average pain averaged over 7 days from randomization to 12 weeks following randomization
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