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A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain

NCT00644787 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2013-06-13

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.

Conditions

Interventions

DRUG

Fentanyl 1-day transdermal patch (Titration Phase)

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.

DRUG

Fentanyl 1-day transdermal patch (Double Blind Phase)

Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

DRUG

Fentanyl 3-day transdermal patch (Double Blind Phase)

Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

DRUG

Placebo

Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

DRUG

Placebo

Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00644787 on ClinicalTrials.gov