Status:
COMPLETED
An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Pain
Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00641667
Start Date
January 1 2008
End Date
June 1 2008
Last Update
June 7 2013
Active Locations (1)
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1
Kitakyushu, Japan