A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Morphine; Tapentadol

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.