A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Cancer
Intervention: Fentanyl 1-day transdermal patch (Titration Phase) (Drug); Fentanyl 1-day transdermal patch (Double Blind Phase) (Drug); Fentanyl 3-day transdermal patch (Double Blind Phase) (Drug); Placebo (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Janssen Pharmaceutical K.K. Official(s) and/or principal investigator(s): Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.
Summary
The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day
application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so
the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl
1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch
in participants with cancer pain.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants Achieving Dose Titration SuccessChange From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase
Secondary outcome: Number of Participants With Response Based on Participant's Global Assessment Scale in Titration PhaseNumber of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase Percentage of Participants Achieving Pain Control in Double Blind Phase Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase Number of Participants With Total Duration of Pain Per Day in Titration Phase Number of Participants With Total Duration of Pain Per Day in Double Blind Phase Mean Number of Rescue Doses in Titration Phase Mean Number of Rescue Doses in Double Blind Phase Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Asahikawa N/A, Japan
Asahikawa, Japan
Asahi, Japan
Bunkyo, Japan
Chiba, Japan
Chikushino, Japan
Fukuoka, Japan
Fushimi, Japan
Higashi-Ibaraki, Japan
Higashi-Sonogi, Japan
Himeji, Japan
Hirosaki, Japan
Hiroshima, Japan
Hitachi, Japan
Hohfu, Japan
Ichinomiya, Japan
Ikeda, Japan
Iwakuni, Japan
Kawachi-Nagano, Japan
Kawasaki N/A, Japan
Kitakyushu, Japan
Kiyose N/A, Japan
Kobe, Japan
Kochi, Japan
Matsue, Japan
Matsuyama, Japan
Nishinomiya, Japan
Oita, Japan
Okayama, Japan
Osaka N/A, Japan
Osaka, Japan
Otake, Japan
Sakai, Japan
Sendai, Japan
Shigenobu N/A, Japan
Sunto, Japan
Tamaho N/A, Japan
Tokushima N/A, Japan
Tokyo, Japan
Toyohashi, Japan
Tsukuba, Japan
Utsunomiya, Japan
Wako, Japan
Yamaguchi, Japan
Yonago, Japan
Additional Information
Starting date: December 2007
Last updated: June 6, 2013
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