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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

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

Phase: Phase 2

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Rita Jain, MD, Study Director, Affiliation: Abbott


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome:

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.

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

Secondary outcome:

Time-interval weighted sum of pain relief (TOTPAR)

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

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

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

Proportion of subjects experiencing meaningful pain relief after dosing


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


Locations and Contacts

Additional Information

Starting date: November 2005
Last updated: July 22, 2011

Page last updated: August 23, 2015

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