A Phase II/III Study of JNS020QD in Cancer Pain Patients - A Dose-Finding, Double-Blind Study of JNS020QD Compared With JNS005 in Patients Previously Untreated With Opioid Analgesics
20 Years
N/A
Both
Pain, Cancer
Trial Information
A Phase II/III Study of JNS020QD in Cancer Pain Patients - A Dose-Finding, Double-Blind Study of JNS020QD Compared With JNS005 in Patients Previously Untreated With Opioid Analgesics
This is a multi-center (conducted in more than one center) study, consisting of two periods:
Period 1 is open-label (all people know the identity of the intervention), non-comparative
dose titration phase and Period 2 is double blind (neither physician nor participant knows
the treatment that the participant receives), positive control (fentanyl 3-day application
transdermal patch is used as control drug) phase. In Period 1, fentanyl 1-day application
transdermal patch 12.5 microgram per hour (mcg/hr) will be applied to chest, abdomen, upper
arm or thigh and will be maintained for 2 days to ensure the safety of participants. Dose
escalation or reduction will be allowed based on participant's condition from Day 3 to Day
11 and thereafter dose will be maintained from Day 11 to Day 13 with a maximum application
dose of 100 mcg/hr. The total duration of Period 1 is 14 days (a total of 13 applications;
including the day of final patch removal). Participants who met the predefined criteria at
the end of dose titration phase will enter the double blind phase. In double blind phase,
participants will receive either fentanyl 1-day application transdermal patch and placebo
matched to fentanyl 3-day application transdermal patch or fentanyl 3-day application
transdermal patch and placebo matched to fentanyl 1-day application transdermal patch at the
same dose as used at the completion of Period 1. The duration of Period 2 is 10 days.
Efficacy will primarily be evaluated by percentage of participants achieving dose titration
success and change in mean visual analog scale (VAS) score. Participants' safety will be
monitored throughout the study.
Inclusion Criteria:
- Participants with cancer pain who were previously not treated with opioid analgesics
(drug used to control pain)
- Participants with a pain score of greater than or equal to 35 millimeter (mm) on a
100-mm visual analog scale (VAS)
- Participants who are considered to have "insufficient response" to non-opioid
analgesics and require treatment with opioid analgesics by the physician
- Participants who have an established diagnosis of cancer and are notified of the
disease
- Participants who can be hospitalized during Period 1 (dose-titration period)
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)
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Percentage of Participants Achieving Dose Titration Success
Outcome Description:
Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.
Outcome Time Frame:
Day 14 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:
CR014899
NCT ID:
NCT00644787
Start Date:
December 2007
Completion Date:
October 2008
Related Keywords:
- Pain
- Cancer
- Pain
- Cancer
- Fentanyl
- JNS020QD
- JNS005
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