Clinical trial NCT00644787: A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Cancer
Keywords: Pain
Cancer
Fentanyl
JNS020QD
JNS005
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percentage of Participants Achieving Dose Titration Success
timeFrame: Day 14 or early discontinuation (ED)
measure: Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase
timeFrame: Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)
Secondary outcomes:
measure: Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
timeFrame: Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED
measure: Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
timeFrame: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
measure: Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
timeFrame: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED
measure: Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
timeFrame: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
measure: Percentage of Participants Achieving Pain Control in Double Blind Phase
timeFrame: Day 10 or ED
measure: Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
timeFrame: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED
measure: Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase
timeFrame: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
measure: Number of Participants With Total Duration of Pain Per Day in Titration Phase
timeFrame: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED
measure: Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
timeFrame: Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
measure: Mean Number of Rescue Doses in Titration Phase
timeFrame: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED
measure: Mean Number of Rescue Doses in Double Blind Phase
timeFrame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
measure: Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase
timeFrame: Day 14
measure: Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase
timeFrame: Day 10
Other outcomes:
Locations:
city: Asahikawa N/A
country: Japan
city: Asahikawa
country: Japan
city: Asahi
country: Japan
city: Bunkyo
country: Japan
city: Chiba
country: Japan
city: Chikushino
country: Japan
city: Fukuoka
country: Japan
city: Fushimi
country: Japan
city: Higashi-Ibaraki
country: Japan
city: Higashi-Sonogi
country: Japan
city: Himeji
country: Japan
city: Hirosaki
country: Japan
city: Hiroshima
country: Japan
city: Hitachi
country: Japan
city: Hohfu
country: Japan
city: Ichinomiya
country: Japan
city: Ikeda
country: Japan
city: Iwakuni
country: Japan
city: Kawachi-Nagano
country: Japan
city: Kawasaki N/A
country: Japan
city: Kitakyushu
country: Japan
city: Kiyose N/A
country: Japan
city: Kobe
country: Japan
city: Kochi
country: Japan
city: Matsue
country: Japan
city: Matsuyama
country: Japan
city: Nishinomiya
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Osaka N/A
country: Japan
city: Osaka
country: Japan
city: Otake
country: Japan
city: Sakai
country: Japan
city: Sendai
country: Japan
city: Shigenobu N/A
country: Japan
city: Sunto
country: Japan
city: Tamaho N/A
country: Japan
city: Tokushima N/A
country: Japan
city: Tokyo
country: Japan
city: Toyohashi
country: Japan
city: Tsukuba
country: Japan
city: Utsunomiya
country: Japan
city: Wako
country: Japan
city: Yamaguchi
country: Japan
city: Yonago
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: