drugset / Trial / NCT01309386

A Safety and Efficacy Study of Oral Tapentadol Extended-Release in Japanese Participants

NCT01309386 ↗

Phase 3 Completed 100 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-08
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Morphine SR Unknown 30 mg Oral
Comparator Morphine SR Unknown 120 mg Oral
Comparator Morphine SR Unknown 140 mg Oral
Subject Tapentadol ER Unknown 100 mg Oral
Subject Tapentadol ER Unknown 400 mg Oral
Subject Tapentadol ER Unknown 500 mg Oral

Indications