DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Success

Change 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 Phase

Number 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017