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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT00745069
Eligibility Criteria:
Inclusion Criteria:
* Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months
* Moderate to severe chronic pain due to knee osteoarithritis
Exclusion Criteria:
* Previously opioid treated subject who had a history of withdrawal after cessation of the opioid
* History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate
* Subjects with history of uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg)
* Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00745069
Study Brief:
Protocol Section:
NCT00745069