A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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