A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Condition: Tumor; Pain
MeSH terms: Cancer Pain
Intervention: Tapentadol Extended Release; Matching Placebo after Tapentadol in the Titration Phase.; Morphine Sulphate Controlled Release
Intervention description: Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 100 mg, increasing at a minimum of 3 day intervals by 50 mg, with a maximum dose of 250 mg.; Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. In the maintenance phase only to participants that were randomized to tapentadol in the titration phase.; Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 40 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.
Intervention MeSH terms: Morphine; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid; Central acting analgesic; CG5503 PR; Tumor related pain; Cancer related pain; Morphine; Pain assessment; Placebo

Summary:

      The purpose of this study will be to determine whether tapentadol (CG5503) is effective and
      safe in the treatment of chronic tumor related pain compared to placebo. In addition
      tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as
      slow release (SR).

      *Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to
      as extended release (ER) in the United States.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male and non-pregnant, non-lactating female subjects.

          -  Of at least 18 years of age with chronic malignant tumor-related pain with a mean pain
             intensity (NRS) of 5 points or higher.

          -  Subjects who are opioid-naïve or pretreated with an equianalgesic dose range
             equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior
             treatment.

          -  Women must be postmenopausal, surgically sterile, or practicing or agree to practice
             an effective method of birth control throughout the trial.

          -  Expected course of the disease and the pain that would permit compliance with the
             trial protocol over the entire trial period.

        Exclusion Criteria

        Key Exclusion Criteria:

          -  Subjects will be excluded from the study if they have a history of seizure disorder or
             epilepsy;

          -  known history and/or presence of cerebral tumor or cerebral metastases.

          -  history of alcohol or drug abuse;

          -  uncontrolled hypertension,

          -  clinical laboratory values reflecting severe renal insufficiency,

          -  moderate or severe hepatic impairment,

          -  hepatitis B or C, HIV,

          -  inadequate bone marrow reserve

          -  currently treated with radiotherapy,

          -  pain-inducing chemotherapy,

          -  anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin
             norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than
             investigational medication or rescue medication during the trial.

          -  selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at
             least 30 days before the screening period of the study at an unchanged dose.