At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Chronic malignant tumor-related pain with mean pain intensity ≥5 on Numeric Rating Scale
- ✓Opioid-naïve or pretreated with ≤160 mg oral morphine equivalent per day with dissatisfaction with prior treatment
- ✓Able to comply with trial protocol over entire trial period
- ✕History of seizure disorder or epilepsy
- ✕Cerebral tumor or cerebral metastases
- ✕History of alcohol or drug abuse
- ✕Uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain
In Brief
A Phase 3 clinical trial evaluating Tapentadol Extended Release, Matching Placebo after Tapentadol in the Titration Phase., and 1 other intervention for Tumor and Pain. Completed, enrolled 622 participants across 71 sites in 16 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.