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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: November 26, 2006
Last updated: July 22, 2011
Last verified: July 2011

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 Intervention Phase
Drug: Hydrocodone/Acetaminophen Extended-Release
Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-interval weighted sum of pain relief (TOTPAR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time-interval weighted sum of pain relief and pain intensity difference (SPRID) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time to first noticeable pain relief (i.e., onset of pain relief) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing meaningful pain relief after dosing [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
Placebo Comparator: Placebo Drug: Placebo
q 4 hours x 3
Other Name: placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404222

Sponsors and Collaborators
Study Director: Rita Jain, MD Abbott
  More Information

No publications provided

Responsible Party: Victor Jorden, MD, Abbott
ClinicalTrials.gov Identifier: NCT00404222     History of Changes
Other Study ID Numbers: M05-772
Study First Received: November 26, 2006
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Acute Pain following Bunionectomy

Additional relevant MeSH terms:
Acetaminophen, hydrocodone drug combination
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014