A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 26, 2006

Last Updated Date

July 23, 2007

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00404222 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)
Time to first noticeable pain relief (i.e., onset of pain relief)
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline
Time to rescue medication
Proportion of subjects using rescue medication
Proportion of subjects experiencing meaningful pain relief after dosing
Mean pain relief and pain intensity at each scheduled pain evaluation and the subject global evaluation

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

Official Title ^ICMJE

A Randomized, Multicenter, Single-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) 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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, 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

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR)
Drug: Immediate Release Hydrocodone/Acetaminophen (NORCO® )

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

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females ages 18 to 65
Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
Must meet specific pain intensity criteria on the morning after surgery
Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
Has a history of or currently has any active seizure disorder
Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
Has been diagnosed with cancer within the past 3 years
Requires treatment with certain drugs for depression or psychiatric disorders
Has specific clinically significant illnesses or laboratory abnormalities
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

Administrative Information

NCT ID ^ICMJE

NCT00404222

Responsible Party

Study ID Numbers ^ICMJE

M05-772

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