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

Condition(s) targeted: Cancer; Pain

Intervention: fentanyl (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

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).

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

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome: 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

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

802-0803 Kita Kyusyu-Shi, Japan; Recruiting

To learn how to participate in this trial please click here.

Starting date: December 2007
Last updated: July 31, 2008