An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
CompletedPhase 3NCT00487435
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Brief summary (from the registry)
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.
Study details
- Official title
- Open-Label Extension, Single-Arm, Flexible-Dosing, Phase 3 Trial With CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain
- Conditions
- Interventions
- Drug: Tapentadol (CG5503) Extended Release (ER)
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Collaborators
- GrĂ¼nenthal GmbH
- Start date
- 2007-06
- Primary completion
- 2009-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, Canada, New Zealand, United States
- Total sites listed
- 148
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (23)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00487435