At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Parallel-Arm, Optimal Dose-Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended-Release (ER) in Japanese Subjects Treated With Around-the-Clock Opioid Analgesics for Their Moderate to Severe Chronic Malignant Tumor- Related Cancer Pain
In Brief
A Phase 3 clinical trial evaluating Tapentadol ER and Morphine SR for Neoplasms. Completed, enrolled 100 participants across 22 sites.
Detailed Summary
The purpose of this study is to evaluate the conversion rate based on the number of participants achieving pain control and safety within 1 week after switching the opioid (morphine-like medications) analgesics (drug used to control pain), when tapentadol extended-release (ER) (JNS024ER) is orally administered to participants treated with around-the-clock opioid analgesics, for their moderate to severe (very serious, life threatening) chronic (lasting a long time) malignant (cancerous) tumor-related (a mass in a specific area) cancer (abnormal tissue that grows and spreads in the body) pain.
Study Details
Timeline
Interventions
Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.
Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.