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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00364533
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection)
* Baseline pain intensity \>= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization
* Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study
Exclusion Criteria:
* Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
* history of malignancy within the past 2 years before starting the study
* history of alcohol or drug abuse
* evidence of active infections that may spread to other areas of the body
* clinical laboratory values reflecting moderate or severe kidney insufficiency
* currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor \[SSRI\] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00364533
Study Brief:
Protocol Section:
NCT00364533