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

NCT03967327 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2019-06-11

No results posted yet for this study

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.

Conditions

  • Cancer Pain

Interventions

DRUG

Buprenorphine transdermal patches

It should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. The skin should be relatively hairless. If none are available, the hair at the site should be clipped, not shaven.

DRUG

Morphine Sulfate Sustained-Release Tablet

It will be administered orally twice (q12h) daily.

Sponsors & Collaborators

  • Mundipharma (China) Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Shukui Qin · The 81st hospital of the people's liberation army

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03967327 on ClinicalTrials.gov