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A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer

NCT00943566 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-09-15

No results posted yet for this study

Summary

The study hypothesis is that the safety and efficacy of sufentanil following transdermal application is comparable to sustained release morphine sulphate tablets in patients with chronic pain due to cancer.

Conditions

Interventions

DRUG

Sufentanil

Transdermal Delivery System; Apply up to six 3 cm2 sufentanil TDS patches every 3 days for 12 days of observation. The 12 days of observation begin after a 7 day conversion to sustained release morphine sulfate. If the subject continues on the pharmacokinetic portion of the study, an additional 6 days of intervention will be evaluated (at the same dose as the primary efficacy study).

DRUG

Sustained Release Morphine Sulfate

Sustained Release Morphine Sulfate tablets every 12 hours; up to 400 mg every day for 19 days (7 days of conversion to sustained release morphine sulfate and 12 days of observation)

Sponsors & Collaborators

  • Labtec GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-12-31
Completion
2011-02-28

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Entities

Diseases

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 NCT00943566 on ClinicalTrials.gov