Status:
COMPLETED
A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Pain
Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
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 b...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00644787
Start Date
December 1 2007
End Date
October 1 2008
Last Update
June 13 2013
Active Locations (43)
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1
Asahi, Japan
2
Asahikawa, Japan
3
Bunkyō City, Japan
4
Chiba, Japan