A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

November 26, 2006

Last Updated Date

April 21, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time-interval-weighted sum of pain relief (TOTPAR) score for 0 to 12 hours following the first dose of study drug administration.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00404391 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time-interval-weighted sum of pain intensity difference (SPID) scores
Time interval weighted sum of pain relief and pain intensity difference (SPRID)
Time to first noticeable pain relief (i.e., onset of pain)
Time to first meaningful pain relief (i.e, 50% reduction in pain from baseline)
Time to rescue medication
Proportion of subjects experiencing meaningful pain relief after dosing
Mean pain relief and pain intensity at each scheduled pain evaluation
Subject Global Evaluation

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

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 Hydrocodone/Acetaminophen 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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Hydrocodone/Acetaminophen (Vicodin® CR)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

210

Completion Date

March 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female ages 18 to 65
Females must be of non-childbearing potential or practicing birth control
Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

Exclusion Criteria:

Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
Is associated with any currently ongoing research study

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00404391

Responsible Party

Study ID Numbers ^ICMJE

M03-609

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Rita Jain, MD

Abbott

Information Provided By

Abbott

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP