A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics
20 Years
N/A
Both
Pain, Cancer
Trial Information
A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics
This is an open-label (all people know the identity of the intervention), multi-center
(conducted in more than one center) and non-comparative study of fentanyl one-day
transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7
days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated
at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined
based on the daily dose of the opioid analgesic taken by the participant before entering the
study and will be maintained for 2 days to ensure safety of participants. Dose escalation or
reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter
dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and
the maximum application dose will be 300 mcg/hr. The patch will be applied on areas
including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a
total of 9 applications; including the day of final patch removal). Efficacy will primarily
be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored
throughout the study.
Inclusion Criteria:
- Participants receiving any of the following drugs at a stable dose 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 less than or equal to 314 milligram per day
(mg/day) as an oral morphine equivalent dose of less than or equal to 157 mg/day for
suppository or less than or equal to 104 mg/day for injection, oral oxycodone
preparations at less than or equal to 209 mg/day, fentanyl citrate injection at less
than or equal to 2.0 mg/day, fentanyl patch less than or equal to 7.5 mg
- Participants assumed to use not more than 2 rescue doses (dose of a fast-acting
opioid analgesic except fentanyl preparations used for lack of analgesic effect)
daily for at least 3 days before the start of application of the study drug
- Participants showing a pain intensity of less than or equal to 34 millimeter (mm) on
a 100-mm visual analog scale (VAS)
- Participants who have an established diagnosis of cancer and are notified of the
disease
- Participants who can be hospitalized during the course of application of the study
drug
Exclusion Criteria:
- Participants with impaired respiratory function due to chronic lung disease or others
- Participants with asthma (breathing disorder in which there is wheezing and
difficulty in breathing or participants with bradyarrhythmia (slow, irregular
heartbeats)
- Participants with following measurements indicative of hepatic or renal impairment
during the pre-treatment observation period: Aspartate transaminase (AST) greater
than 5 times the upper limit of reference range, Alanine transaminase (ALT) greater
than 5 times the upper limit of reference range, serum creatinine greater than 3
times the upper limit of reference range
- Participants with any cerebral damage, such as brain tumor, accompanied by increased
intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance
- Participants with a history of hypersensitivity to fentanyl or other opioid
analgesics
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants Achieving Pain Control
Outcome Description:
Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.
Outcome Time Frame:
Day 10 or early discontinuation (ED)
Safety Issue:
No
Principal Investigator
Janssen Pharmaceutical K.K., Japan Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Janssen Pharmaceutical K.K.
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CR014896
NCT ID:
NCT00641667
Start Date:
January 2008
Completion Date:
June 2008
Related Keywords:
- Pain
- Cancer
- Pain
- Cancer
- Fentanyl
- JNS020QD
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