Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT00226395
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2005-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
Sponsor:
Endo Pharmaceuticals
Organization:
Study Overview
Official Title:
Randomized, Double-Blind, Placebo- and Active-Control, Single- and Multiple-Dose Evaluation of the Analgesic Efficacy and Safety of Oxymorphone Immediate Release (IR) Tablets in Patients With Moderate/Severe Pain Following Abdominal Surgery
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 two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.
Detailed Description:
Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: