Phase 3
Completed N=1,154
An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Source: ClinicalTrials.gov NCT00487435 ↗Enrolled (actual)
1,154
Serious AEs
7.3%
Results posted
Jul 2010
Primary outcomePrimary: Number of Subjects With Treatment-emergent Adverse Events (TEAE) — 907 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events (TEAE) |
907 | — |
| SECONDARY Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) |
-0.26 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00487435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.