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Completed

NCT Number: NCT00404391

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Ref # / Investigator 4993, Owing Mills, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone/Acetaminophen Extended Release

Drug

1 tablet every 12 hours

Other names: ABT-712

Placebo

Drug

2 tablets every 12 hours

Primary outcomes

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

    Time frame: 12 hours

    Pain relief measured by a 100mm Visual Analog Scale (VAS)

Secondary outcomes

  1. Time interval weighted sum of pain intensity difference (SPID)scores

    Time frame: 12 hours

    Sum of pain intensity difference

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Nov 28, 2006
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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