Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226421
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2005-09-23
Brief Title:
Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Non-Malignant Pain
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
An Open-Label Titration Followed by a Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy Tolerability and Safety of Oxymorphone Extended Release Tablets in Opioid-Experienced Patients With Chronic Low Back Pain
Status:
COMPLETED
Status Verified Date:
2023-12
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 analgesic efficacy and safety of oxymorphone extended release in opioid-experienced patients with chronic low back pain
Detailed Description:
Patients with chronic low back pain on stable opioid treatment will be converted to oxymorphone extended release ERand enter an open-label treatment phaseDuring the Open-Label Titration Period up to 28 days patients will receive daily oxymorphone ER PO q12h Patients stabilized on a dose that provides adequate pain relief will be randomized to either continue on the stabilized dose of oxymorphone ER or receive placebo in a double-blind fashion for a total duration of 12 weeks
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