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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• 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

• 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.