An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Condition: Pain; Osteoarthritis; Low Back Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain; Chronic Pain
Intervention: Tapentadol (CG5503) Extended Release (ER)
Intervention description: 100, 150, 200, 250 mg oral tablet twice daily for 52 weeks
Intervention MeSH terms: Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1166.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CG5503; Tapentadol; chronic non-malignant pain; osteoarthritis; lower back pain; analgesic; opioid

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.
    

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.