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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00404222
First received: November 26, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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
Pain
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404222

Sponsors and Collaborators
Abbott
Investigators
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:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
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 August 27, 2014