An Effectiveness and Safety Study of Fentanyl in Patients With Cancer Pain Changing From Opioid Analgesics

Condition(s) targeted: Pain; Cancer

Intervention: Fentanyl (Drug)

Phase: 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) switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection, or fentanyl patch in patients with various types of cancer pain

Official title: A Phase 3 Confirmatory Study for Efficacy and Safety of JNS020 QD(Fentanyl) in Patients With Cancerous Pains Who Change From Opioid Analgesics to JNS020 QD(Fentanyl).

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Pain control achievement rate (calculated based on the changes of both VAS score and number of daily rescue dose from baseline at treatment end)

Secondary outcome: Patient's global assessment, pain intensity (VAS), 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. This is a multicenter, open-label, uncontrolled study to evaluate the effectiveness and safety of JNS020 QD(fentanyl) switched from opioid analgesics. An initial dose of JNS020 QD(fentanyl) is calculated based on the dose of prior opioid analgesics, subsequently the dose of JNS020 QD(fentanyl) can be increased up to 300 mcg/h. Primary outcome of this study is the pain control achievement rate (calculated based on the changes of both VAS score and number of daily rescue dose from baseline at treatment end) . Adverse event reporting, laboratory tests, measurements of vital signs and electrocardiogram are conducted for safety evaluation.

An initial dose of JNS020 QD(fentanyl) is calculated based on the dose of prior opioid analgesics using a conversion table. Subsequently dose of JNS020 QD(fentanyl) can be increased up to 300 mcg/h according to the patient's condition. The duration of administration is 10 days.

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

Criteria:

Inclusion Criteria:

- Cancer pain patients receiving any of the following drugs which are expected to be

used at a stable dose (except for a rescue drug) for at least 3 days (or 9 days in case of fentanyl patch) before the start of application of the study drug: Morphine preparations at <= 314 mg/day as an oral morphine equivalent dose(<=157 mg/day for suppository, <= 104 mg/day for injection), Oral oxycodone preparations at <= 209 mg/day, Fentanyl citrate injection at <= 2. 0 mg/day, Fentanyl patch <= 7. 5 mg

- Patients assumed to use not more than 2 rescue doses daily for at least 3 days before

the start of application of the study drug

- Patients showing a pain intensity of <= 34 mm on a 100-mm visual analog scale (VAS)

- Patients who have an established diagnosis of cancer and are notified of the disease

- Patients who can be hospitalized during the course of application of the study drug

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: June 12, 2008