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Completed

NCT Number: NCT00402792

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

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.

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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 3

Primary location

Site Ref # / Investigator 2589, Austin, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Hydrocodone/Acetaminophen Extended-Release

Drug

1 tablet q 12 hours

Other names: ABT-712, hydrocodone / acetaminophen extended release

Hydrocodone/Acetaminophen Extended Release

Drug

2 tablets q 12 hours

Other names: ABT-712, hydrocodone / acetaminophen extended release

Placebo

Drug

2 tablets q 12 hours

Primary outcomes

  1. 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.

    Time frame: 12 hours

    Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)

Secondary outcomes

  1. Time-interval weighted sum of pain relief (TOTPAR)

    Time frame: 12 hours

  2. Time-interval weighted sum of pain relief and pain intensity difference (SPRID)

    Time frame: 12 hours

  3. Perceptible pain relief

    Time frame: 12 hours

  4. Meaningful pain relief

    Time frame: 12 hours

  5. Pain relief (PR)

    Time frame: 12 hours

  6. Pain intensity (PI)

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Jan 25, 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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