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

Sponsor:	Janssen Pharmaceutical K.K.
Information provided by:	Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:	NCT00641667

Purpose

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

Condition	Intervention	Phase
Cancer Pain	Drug: JNS020QD	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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).

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:

Pain control achievement rate (calculated based on the changes of both VAS score and number of daily rescue dose from baseline at treatment end) [ Time Frame: From the first system application (Day 1) to the last system application (Day 10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient's global assessment, pain intensity (VAS), pain intensity (categorical scale), total duration of pain per day, rescue dose, physician's global assessment [ Time Frame: From the first system application (Day 1) to the last system application (Day 10) ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001	Drug: JNS020QD continuous application of JNS020QD patch (12.5-300 ug/h) for 10 days

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641667

Sponsors and Collaborators

Janssen Pharmaceutical K.K.

Investigators

Study Director:

Janssen Pharmaceutical K.K. Clinical Trial

Janssen Pharmaceutical K.K.

More Information

No publications provided

Responsible Party:	Director of Clinical R&D Dept.3, Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:	NCT00641667 History of Changes
Other Study ID Numbers:	CR014896, JNS020QD-JPN-C01
Study First Received:	March 17, 2008
Last Updated:	April 26, 2010
Health Authority:	Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center

Keywords provided by Janssen Pharmaceutical K.K.:

cancer
pain
control
opioid analgesics
patch

Additional relevant MeSH terms:

Analgesics
Fentanyl
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012