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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00404222
Recruitment Status : Completed
First Posted : November 28, 2006
Last Update Posted : July 25, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Hydrocodone/Acetaminophen Extended-Release Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official 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
Study Start Date : November 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: hydrocodone / acetaminophen extended release Drug: Hydrocodone/Acetaminophen Extended-Release
2 tablets x 1
Other Name: hydrocodone / acetaminophen extended release

Active Comparator: Hydrocodone/Acetaminophen Immediate Release (Norco ®) Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
1 tablet q 4 hours x 3

Placebo Comparator: Placebo Drug: Placebo
q 4 hours x 3

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00404222

Sponsors and Collaborators
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Study Director: Rita Jain, MD Abbott

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Responsible Party: Victor Jorden, MD, Abbott Identifier: NCT00404222    
Other Study ID Numbers: M05-772
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011
Keywords provided by Abbott:
Acute Pain following Bunionectomy
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents