A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 20, 2006

Last Updated Date

October 24, 2007

Start Date ^ICMJE

December 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00402792 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time-interval weighted sum of pain relief (TOTPAR)
Time-interval weighted sum of pain intensity (SPID) using the categorical pain intensity scale
Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
Perceptible pain relief
Meaningful pain relief
Rescue/supplemental medication use
Pain relief (PR)
Pain intensity (PI)
Subject Global Assessment of Study Drug

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy

Official Title ^ICMJE

A Randomized, Multicenter, Double-Blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy

Brief Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to 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 III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Extended-Release 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

Estimated Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females ages 18 to 65
Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
Meet specific pain intensity criteria on the morning after surgery
Willing to be confined for 4 days following surgery
If female, must be of non-child bearing potential or practicing birth control

Exclusion Criteria:

Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
Has specific active or uncontrolled seizure disorders
Has been diagnosed with certain cancers within the past 5 years
Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
Has specific clinically significant illnesses or laboratory abnormalities
Has received corticosteroid treatment or any investigational drug within a specific timeframe

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

United States

Administrative Information

NCT ID ^ICMJE

NCT00402792

Responsible Party

Study ID Numbers ^ICMJE

M05-765

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Rita Jain, MD

Abbott

Information Provided By

Abbott

Verification Date

October 2007

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