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Completed

NCT Number: NCT00404222

A Study Comparing Vicodin® CR and NORCO® to Placebo 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 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.

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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

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
  • 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.

Treatment and study plan

Hydrocodone/Acetaminophen Extended-Release

Drug

2 tablets x 1

Other names: hydrocodone / acetaminophen extended release

Hydrocodone/Acetaminophen Immediate Release (NORCO®)

Drug

1 tablet q 4 hours x 3

Placebo

Drug

q 4 hours x 3

Primary outcomes

  1. 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.

    Time frame: 12 hours

  2. Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)

    Time frame: 12 hours

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. Time to first noticeable pain relief (i.e., onset of pain relief)

    Time frame: 12 hours

  4. Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)

    Time frame: 12 hours

  5. Proportion of subjects experiencing meaningful pain relief after dosing

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 28, 2006
Registry last updated
Jul 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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