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:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT00601458
Eligibility Criteria:
Inclusion Criteria:
* Patient is a man or woman between 18 and 65 years of age
* For Women of Child-bearing potential: woman who is currently not pregnant not nursing and who is willing to use a medically acceptable method of birth control from the time after the screening visit until completion of the follow-up visit
* Patient is scheduled to have a bunionectomy
* Patient must be willing to stay at the study site throughout the 48-hour observation period following surgery and is willing to complete a 2-week follow up
* Patient is capable of operating a Patient Controlled Analgesia device
Exclusion Criteria:
* Patient is being treated for a disease and has not been on a stable dose of medication for at least 2 weeks prior to surgery
* Patient has used or intends to use any of the medications that are prohibited by the protocol, which could interfere with the evaluation of the study drugs
* Patient has an estimated creatinine clearance of \< or = 60 mL per min
* Patient has a history of drug abuse or dependence, or patient has a positive urine drug screen
* Patient has a condition that prevents clear communication concerning pain perception (such as diabetic neuropathy, peripheral neuropathy, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00601458
Study Brief:
Protocol Section:
NCT00601458