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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00487435
Eligibility Criteria:
Inclusion Criteria:
* Non-lactating female subjects (Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control \[e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization\] before entry and throughout the trial. Female patients of childbearing potential must have a negative pregnancy test at screening.)
* Completion of the expected double-blind treatment period of the pivotal Tapentadol (CG5503) Phase 3 trials in osteoarthritis (R331333-PAI-3008, KF5503/11) or low back pain (R331333-PAI-3011, KF5503/23), or completion of the 1-year treatment period of the safety CG5503 Phase 3 trial in the non-European sites (R331333-PAI-3007, KF5503/24)
* Must be willing to take Tapentadol (CG5503) extended release (ER) and the rescue medication supplied for the duration of the trial
Exclusion Criteria:
* History of alcohol and/or drug abuse, life-long history of seizure disorder or epilepsy, any of the following within the past year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
* Severe traumatic brain injury within the past 15 years
* Uncontrolled hypertension (repeated systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg)
* Severely impaired renal function
* Moderately or severely impaired hepatic function
* Patients taking neuroleptics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00487435
Study Brief:
Protocol Section:
NCT00487435