A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine
Condition: Pain; Neoplasm; Cancer
MeSH terms: Cancer Pain
Intervention: Tapentadol in the Titration Phase; Morphine in the Maintenance Phase; Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase; Tapentadol in the Maintenance Phase; Morphine in the Titration Phase
Intervention description: Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted. In the maintenance phase participants continued on the dose level established in titration phase.
Participants randomized to the morphine arm remained on morphine if they qualified for the maintenance phase of the study. The participants were maintained on the dose established at the end of the titration phase. The adverse events listed were documented in the maintenance phase.; Participant randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.; The participants re-randomized to receive tapentadol prolonged release in the maintenance phase were maintained on the dose established in the titration phase.; After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses). Participant started the trials with 45 mg morphine controlled release twice daily. Upward titration could then occur at a minimum of 3-day intervals in increments of 15 mg morphine twice daily. The maximum dose of morphine controlled release was 90 mg twice daily. Downward titration (but not below 45 mg twice daily) was permitted.
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: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Tumor Related Pain; Analgesic; Tapentadol Extended Release; Morphine Sulfate Controlled Release; Pain assessment; Placebo

Summary:

      The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe
      in the treatment of chronic tumor related pain compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed informed consent document.

          -  Male and non-pregnant, non-lactating female subjects.

          -  Female subjects must be post menopausal, surgically sterile, or practicing an
             effective method of birth control and continue to do so throughout the trial.

          -  At least 18 years of age.

          -  Have chronic malignant tumor-related pain

          -  Are opioid-naïve or have been pretreated with an equianalgesic dose range equivalent
             of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.

          -  Have a mean pain intensity of at least 5 points on an 11-point Numeric Rating Scale
             (where 0 indicates no pain and 10 indicates worst possible pain).

          -  Have an expected course of the disease such that the pain that will permit compliance
             with the trial protocol over the entire trial period.

        Exclusion Criteria:

          -  Have a life-long history of seizure disorder or epilepsy.

          -  Have had any of the following within one year: mild/moderate traumatic brain injury,
             stroke, and transient ischemic attack.

          -  Have had severe traumatic brain injury within 15 years (consisting of ≥ 1 of the
             following: brain contusion, intracranial hematoma, and either unconsciousness or
             post-traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting
             transient changes in consciousness.

          -  Have a known history and/or presence of cerebral metastases.

          -  Have moderately or severely impaired hepatic function.

          -  Have laboratory values reflecting inadequate hepatic function.

          -  Have thrombopenia, leucopenia or hypercalcemia

          -  Have severely impaired renal function.

          -  Having uncontrolled hypertension

          -  Having clinically relevant history of hypersensitivity, allergy or contraindications
             to morphine or any of the excipients.

          -  Have chronic hepatitis B or hepatitis C, or Human Immunodeficiency Virus (HIV).

          -  Subjects currently undergoing the following concomitant therapy: radiotherapy, pain
             inducing chemotherapy, anti-parkinsonian drugs, neuroleptics, monoamine oxidase
             inhibitors, serotonin norepinephrine re-uptake inhibitors (SNRI) or any other
             analgesic therapy than investigational medication or rescue medication during the
             trial. Selective serotonin re-uptake inhibitor (SSRI) treatments are allowed if taken
             for at least 30 days before the screening period of the trial at an unchanged dose.