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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cancer; Pain

Treatments: Drug: Fentanyl 3-day transdermal patch (Double Blind Phase); Drug: Fentanyl 1-day transdermal patch (Titration Phase); Drug: Fentanyl 1-day transdermal patch (Double Blind Phase); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644787

CR014899

JNS020QD-JPN-C02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

Fentanyl 1-day transdermal patch (Titration Phase)

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl 1-day transdermal patch (Titration Phase)

Fentanyl 1-day transdermal patch (Double Blind Phase)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Fentanyl 1-day transdermal patch (Double Blind Phase)

Fentanyl 3-day transdermal patch (Double Blind Phase)

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Fentanyl 3-day transdermal patch (Double Blind Phase)