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drugset / Trial / NCT03967327

A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain

NCT03967327 ↗

Phase 3 Unknown 194 enrolled Mundipharma (China) Pharmaceutical Co. Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomised, active-controlled, double-blind, double-dummy, parallel group study with BUP TDS 20 mg (release rate 35 µg/h), 30 mg (release rate 52.5 µg/h) and 40 mg (release rate 70 µg/h), and MOR SR 60 mg, 100 mg or 120 mg per day. The study consists of 3 phases: a Pre-randomisation Phase, a Double-blind Phase and a Safety Follow-up Phase. There will be 194 subjects to be randomized, with 97 randomized subjects in each arm to ensure 154 evaluable (per protocol population) subjects in the study.

Timeline

Start
2019-04-22
Primary completion
2020-12-20
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 20 mg Topical
Subject Buprenorphine Other / unclassified 30 mg Topical
Subject Buprenorphine Other / unclassified 40 mg Topical
Subject Morphine Other / unclassified 60 mg Oral
Subject Morphine Other / unclassified 100 mg Oral
Subject Morphine Other / unclassified 120 mg Oral

Indications

No indication recorded.