An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) t… (NCT00487435) | Clinical Trial Compass
CompletedPhase 3
An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
United States1,166 participantsStarted 2007-06
Plain-language summary
The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes.
Who can participate
Age range18 Years
SexALL
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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 inhibitor…
What they're measuring
1
Number of Subjects With Treatment-emergent Adverse Events (TEAE)
Timeframe: 52 weeks
Trial details
NCT IDNCT00487435
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.