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

NCT ID: NCT00644787

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-10-31

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 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.

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.

Conditions

Pain; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fentanyl 1-day transdermal patch (Titration Phase)

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase.

Group Type: EXPERIMENTAL

Fentanyl 1-day transdermal patch (Titration Phase)

Intervention Type: DRUG

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.

Fentanyl 1-day transdermal patch (Double Blind Phase)

Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Group Type: EXPERIMENTAL

Fentanyl 1-day transdermal patch (Double Blind Phase)

Intervention Type: DRUG

Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Placebo

Intervention Type: DRUG

Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Fentanyl 3-day transdermal patch (Double Blind Phase)

Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Group Type: ACTIVE_COMPARATOR

Fentanyl 3-day transdermal patch (Double Blind Phase)

Intervention Type: DRUG

Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Placebo

Intervention Type: DRUG

Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Interventions

Fentanyl 1-day transdermal patch (Titration Phase)

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.

Intervention Type: DRUG

Fentanyl 1-day transdermal patch (Double Blind Phase)

Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Intervention Type: DRUG

Fentanyl 3-day transdermal patch (Double Blind Phase)

Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Intervention Type: DRUG

Placebo

Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Intervention Type: DRUG

Placebo

Placebo matching to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days.

Intervention Type: DRUG

Other Intervention Names

JNS020QD; JNS020QD; JNS005

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Asahi, , Japan

Asahikawa, , Japan

Bunkyō City, , Japan

Chiba, , Japan

Chikushino-shi, , Japan

Fukuoka, , Japan

Fushimi, , Japan

Higashi-Ibaraki, , Japan

Himeji, , Japan

Hirosaki, , Japan

Hiroshima, , Japan

Hitachi, , Japan

Hohfu, , Japan

Ichinomiya, , Japan

Ikeda, , Japan

Iwakuni, , Japan

Kawachi-Nagano, , Japan

Kawasaki, , Japan

Kitakyushu, , Japan

Kiyose, , Japan

Kobe, , Japan

Kochi, , Japan

Matsue, , Japan

Matsuyama, , Japan

Nishinomiya, , Japan

Okayama, , Japan

Osaka, , Japan

Ōita, , Japan

Ōtake, , Japan

Sakai, , Japan

Sendai, , Japan

Shigenobu N/A, , Japan

Sonogishukugō, , Japan

Sunto, , Japan

Tamaho N/A, , Japan

Tokushima, , Japan

Tokyo, , Japan

Toyohashi, , Japan

Tsukuba, , Japan

Utsunomiya, , Japan

Wako, , Japan

Yamaguchi, , Japan

Yonago, , Japan

Countries

Japan

Other Identifiers

JNS020QD-JPN-C02

Identifier Type: -

Identifier Source: secondary_id

CR014899

Identifier Type: -

Identifier Source: org_study_id