An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• 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 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 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