A Dose-Finding and Double Blinded Study of JNS020 QD(Fentanyl) in Patients With Cancerous Pain Previously Untreated With Opioid Analgesics - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

A Dose-Finding and Double Blinded Study of JNS020 QD(Fentanyl) in Patients With Cancerous Pain Previously Untreated With Opioid Analgesics

This study is ongoing, but not recruiting participants.

Study NCT00644787. Last updated on October 3, 2008. Information provided by Janssen Pharmaceutical K.K.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Dose-Finding and Double Blinded Study of JNS020 QD(Fentanyl) in Patients With Cancerous Pain Previously Untreated With Opioid Analgesics

Official Title ^†

A Phase 2/3 Dose-Finding and Double Blinded Study of JNS020 QD(Fentanyl) in Comparison With JNS005 in Patients With Cancerous Pains Previously Untreated With Opipoid Analgesics

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of JNS020 QD(fentanyl) at an initial dose of 12.5 mcg/h in cancer pain patients who require the use of opioid analgesics because of inadequate response to non-opioid analgesics (e.g., non-steroidal anti-inflammatory drugs) and to assess the noninferiority of JNS020 QD(fentanyl) to JNS005 in effectiveness in patients whose pain is controlled with JNS020 QD(fentanyl).

Detailed Description

Fentanyl patch system for 3-day application is widely used for management of cancer related pain. Patch for 1-day application is useful and it can allow daily dose adjustment, an optimal clinical dose can be selected for patients previously untreated with opioid analgesics. This is a multicenter study to evaluate the effectiveness and safety of JNS020 QD(fentanyl), consisting of two periods. Period 1 is non-blind, uncontrolled, Period 2 is double-blinded, positive control, randomized. JNS005, a fentanyl patch for 3-day application, is used as control drug. Patients receive initially 12.5 mcg/h JNS020 QD(fentanyl), subsequently the dose of JNS020 QD(fentanyl) can be increased up to 100 mcg/h in Period 1. Patients are randomly allocated to either the JNS020 QD(fentanyl) group or the JNS005 group in Period 2. Patients receive JNS020 QD(fentanyl) at the same dose as used at period 1 in the JNS020 QD(fentanyl) group. Patients receive JNS005 at the same daily dose as used at period 1 in the JNS005 group. The duration of period 2 is 10 days. The VAS score changes of each group in period 2 are compared to assess the noninferiority of JNS020 QD(fentanyl) to JNS005.

Patients receive initially 12.5 mcg/h JNS020 QD(fentanyl), subsequently the dose of JNS020 QD(fentanyl) can be increased up to 100 mcg/h in Period 1. The duration of Period 1 is 5 to 14 days. In Period 2, the assigned patch is applied for 10 days at the same dose as used at the end of Period 1.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Period 1: Dose titration success rate Period 2: The mean VAS score for the last 3 days before the completion (or discontinuation) of Period 2 [ Time Frame: The primary outcome measure of Period I is from the first system application (Period 1-Day 1) until the dose is fixed (Up to Period 1-Day14). The primary outcome measure of Period II is from the end of Period I to Period 2- Day 10. ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Patient's global assessment, pain intensity (VAS), pain control achievement rate, pain intensity (categorical scale), total duration of pain per day, rescue dose, physician's global assessment [ Time Frame: The secondary outcome measure of Period I is from the first system application (Period 1-Day 1) until the dose is fixed (Up to Period 1-Day14). The primary outcome measure of Period II is from the end of Period I to Period 2- Day 10. ] [ Designated as safety issue: Yes ]

Condition ^†

Pain
Cancer

Intervention ^†

Drug: JNS020QD: JNS005(Placebo)
Drug: JNS005; JNS020QD(Placebo)
Drug: JNS020QD

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

156

Start Date ^†

December 2007

Completion Date

October 2008

Eligibility Criteria ^†

Inclusion Criteria:

Cancer pain patients previously untreated with opioid analgesics for the pain
Patients treated with non-opioid analgesics (e.g., non-steroidal anti-inflammatory drugs)
Patients with a pain score of >= 35 mm on a 100-mm visual analog scale (VAS)
Patients who are considered to have "insufficient response" to non-opioid analgesics and to require the treatment with opioid analgesics by the physician
Patients who have an established diagnosis of cancer and are notified of the disease

Exclusion Criteria:

Patients with impaired respiratory function due to chronic lung disease or others
Patients with asthma
Patients with bradyarrhythmia
Patients who are found to have any of the following measurements indicative of hepatic or renal impairment with laboratory tests during the pre-treatment observation period: AST (GOT) > 5 times the upper limit of reference range, ALT (GPT) > 5 times the upper limit of reference range, serum creatinine > 3 times the upper limit of reference range
Patients with any organic cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00644787

Organization ID

CR014899

Secondary IDs ^††

JNS020QD-JPN-C02, FENPAI2003

Study Sponsor ^†

Janssen Pharmaceutical K.K.

Collaborators ^††

Investigators ^†

Study Director:

Janssen Pharmaceutical K.K. Clinical Trial

Janssen Pharmaceutical K.K.

Information Provided By

Janssen Pharmaceutical K.K.

Verification Date

October 2008

First Received Date ^†

March 24, 2008

Last Updated Date

October 3, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.