Viewing Study NCT00404391



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00404391
Status: COMPLETED
Last Update Posted: 2011-01-19
First Post: 2006-11-26

Brief Title: A Study Comparing the Analgesic Activity of Extended Release HydrocodoneAcetaminophen Vicodin CR and Placebo in Subjects With Pain Following Bunionectomy Surgery
Sponsor: Abbott
Organization: Abbott

Study Overview

Official Title: A Randomized Double-Blind Placebo-Controlled Study Comparing the Analgesic Activity of HydrocodoneAcetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery
Status: COMPLETED
Status Verified Date: 2011-01
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 level of pain control and safety of the administration of 2 different dose levels of Extended Release HydrocodoneAcetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the safety of the drug for 7 days after patients are discharged from the hospital
Detailed Description: None

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