Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT00402792
Eligibility Criteria:
Inclusion Criteria:
* Males and females ages 18 to 65
* Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
* Meet specific pain intensity criteria on the morning after surgery
* Willing to be confined for 4 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, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
* Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
* Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
* Has specific active or uncontrolled seizure disorders
* Has been diagnosed with certain cancers within the past 5 years
* Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
* Has specific clinically significant illnesses or laboratory abnormalities
* Has received corticosteroid treatment or any investigational drug within a specific timeframe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00402792
Study Brief:
Protocol Section:
NCT00402792