CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 156 enrolled
Drug / intervention
Fentanyl 1-day transdermal patch (Titration Phase) +4 moredrug
Likely dose
Fentanyl 1-day transdermal patch (Titration Phase) 12.5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00644787
NCT00644787Phase 3Completed
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A Phase II/III Study of JNS020QD in Cancer Pain Patients - A Dose-Finding, Double-Blind Study of JNS020QD Compared With JNS005 in Patients Previously Untreated With Opioid Analgesics

Janssen Pharmaceutical K.K.·interventional·Posted Mar 27, 2008·Updated Jun 13, 2013

In Brief

A Phase 3 clinical trial evaluating Fentanyl 1-day transdermal patch (Titration Phase), Fentanyl 1-day transdermal patch (Double Blind Phase), and 2 other interventions for Pain and Cancer. Completed, enrolled 156 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Cancer
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2008
Enrollment StartDec 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.3 years ago

Interventions

Fentanyl 1-day transdermal patch (Titration Phase)drug

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.

Fentanyl 1-day transdermal patch (Double Blind Phase)drug

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.

Fentanyl 3-day transdermal patch (Double Blind Phase)drug

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.

Placebodrug

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.

Placebodrug

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.