Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).

Janssen Pharmaceutical K.K., Japan Clinical Trial

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.

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

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

A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics

Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.

Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.

Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable".

Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.

The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (\<) 4 hours, 1 = greater than or equal to (\>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).

Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.

The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.

Janssen Pharmaceutical K.K.

Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).

Age Continuous

Sex: Female, Male

Director, Clinical Research

Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.

Percentage of Participants Achieving Pain Control

Day 1; Extremely satisfied (n=66)

Day 1; Satisfied (n=66)

Day 1; Neither satisfied nor dissatisfied (n=66)

Day 1; Dissatisfied (n=66)

Day 1; Extremely dissatisfied (n=66)

Day 2; Extremely satisfied (n=65)

Day 2; Satisfied (n=65)

Day 2; Neither satisfied nor dissatisfied (n=65)

Day 2; Dissatisfied (n=65)

Day 2; Extremely dissatisfied (n=65)

Day 3; Extremely satisfied (n=65)

Day 3; Satisfied (n=65)

Day 3; Neither satisfied nor dissatisfied (n=65)

Day 3; Dissatisfied (n=65)

Day 3; Extremely dissatisfied (n=65)

Day 4; Extremely satisfied (n=64)

Day 4; Satisfied (n=64)

Day 4; Neither satisfied nor dissatisfied (n=64)

Day 4; Dissatisfied (n=64)

Day 4; Extremely dissatisfied (n=64)

Day 5; Extremely satisfied (n=63)

Day 5; Satisfied (n=63)

Day 5; Neither satisfied nor dissatisfied (n=63)

Day 5; Dissatisfied (n=63)

Day 5; Extremely dissatisfied (n=63)

Day 6; Extremely satisfied (n=63)

Day 6; Satisfied (n=63)

Day 6; Neither satisfied nor dissatisfied (n=63)

Day 6; Dissatisfied (n=63)

Day 6; Extremely dissatisfied (n=63)

Day 7; Extremely satisfied (n=63)

Day 7; Satisfied (n=63)

Day 7; Neither satisfied nor dissatisfied (n=63)

Day 7; Dissatisfied (n=63)

Day 7; Extremely dissatisfied (n=63)

Day 8; Extremely satisfied (n=62)

Day 8; Satisfied (n=62)

Day 8; Neither satisfied nor dissatisfied (n=62)

Day 8; Dissatisfied (n=62)

Day 8; Extremely dissatisfied (n=62)

Day 9; Extremely satisfied (n=62)

Day 9; Satisfied (n=62)

Day 9; Neither satisfied nor dissatisfied (n=62)

Day 9; Dissatisfied (n=62)

Day 9; Extremely dissatisfied (n=62)

Day 10/ED; Extremely satisfied (n=66)

Day 10/ED; Satisfied (n=66)

Day 10/ED;Neither satisfied nor dissatisfied(n=66)

Day 10/ED; Dissatisfied (n=66)

Day 10/ED; Extremely dissatisfied (n=66)

The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.

Number of Participants With Response Based on Patient's Global Assessment Scale

Day 1 pre-application; (n=66)

Day 2; (n=65)

Day 3; (n=65)

Day 4; (n=64)

Day 5; (n=63)

Day 6; (n=63)

Day 7; (n=63)

Day 8; (n=62)

Day 9; (n=62)

Day 10 or ED; (n=66)

Pain Intensity Visual Analog Scale (VAS) Score

Day 1; No pain (n=66)

Day 1; Mild pain (n=66)

Day 1; Moderate pain (n=66)

Day 1; Severe pain (n=66)

Day 2; No pain (n=65)

Day 2; Mild pain (n=65)

Day 2; Moderate pain (n=65)

Day 2; Severe pain (n=65)

Day 3; No pain (n=65)

Day 3; Mild pain (n=65)

Day 3; Moderate pain (n=65)

Day 3; Severe pain (n=65)

Day 4; No pain (n=64)

Day 4; Mild pain (n=64)

Day 4; Moderate pain (n=64)

Day 4; Severe pain (n=64)

Day 5; No pain (n=63)

Day 5; Mild pain (n=63)

Day 5; Moderate pain (n=63)

Day 5; Severe pain (n=63)

Day 6; No pain (n=63)

Day 6; Mild pain (n=63)

Day 6; Moderate pain (n=63)

Day 6; Severe pain (n=63)

Day 7; No pain (n=63)

Day 7; Mild pain (n=63)

Day 7; Moderate pain (n=63)

Day 7; Severe pain (n=63)

Day 8; No pain (n=62)

Day 8; Mild pain (n=62)

Day 8; Moderate pain (n=62)

Day 8; Severe pain (n=62)

Day 9; No pain (n=62)

Day 9; Mild pain (n=62)

Day 9; Moderate pain (n=62)

Day 9; Severe pain (n=62)

Day 10 or ED; No pain (n=66)

Day 10 or ED; Mild pain (n=66)

Day 10 or ED; Moderate pain(n=66)

Day 10 or ED; Severe pain(n=66)

Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain

Day 1; < 4 hours (n=66)

Day 1; >= 4 to < 8 hours (n=66)

Day 1; >= 8 to < 12 hours (n=66)

Day 1; >= 12 hours (n=66)

Day 1; 24 hours (n=66)

Day 2; < 4 hours (n=65)

Day 2; >= 4 to < 8 hours (n=65)

Day 2; >= 8 to < 12 hours (n=65)

Day 2; >= 12 hours (n=65)

Day 2; 24 hours (n=65)

Day 3; < 4 hours (n=65)

Day 3; >= 4 to < 8 hours (n=65)

Day 3; >= 8 to < 12 hours (n=65)

Day 3; >= 12 hours (n=65)

Day 3; 24 hours (n=65)

Day 4; < 4 hours (n=64)

Day 4; >= 4 to < 8 hours (n=64)

Day 4; >= 8 to < 12 hours (n=64)

Day 4; >= 12 hours (n=64)

Day 4; 24 hours (n=64)

Day 5; < 4 hours (n=63)

Day 5; >= 4 to < 8 hours (n=63)

Day 5; >= 8 to < 12 hours (n=63)

Day 5; >= 12 hours (n=63)

Day 5; 24 hours (n=63)

Day 6; < 4 hours (n=63)

Day 6; >= 4 to < 8 hours (n=63)

Day 6; >= 8 to < 12 hours (n=63)

Day 6; >= 12 hours (n=63)

Day 6; 24 hours (n=63)

Day 7; < 4 hours (n=63)

Day 7; >= 4 to < 8 hours (n=63)

Day 7; >= 8 to < 12 hours (n=63)

Day 7; >= 12 hours (n=63)

Day 7; 24 hours (n=63)

Day 8; < 4 hours (n=62)

Day 8; >= 4 to < 8 hours (n=62)

Day 8; >= 8 to < 12 hours (n=62)

Day 8; >= 12 hours (n=62)

Day 8; 24 hours (n=62)

Day 9; < 4 hours (n=62)

Day 9; >= 4 to < 8 hours (n=62)

Day 9; >= 8 to < 12 hours (n=62)

Day 9; >= 12 hours (n=62)

Day 9; 24 hours (n=62)

Day 10 or ED; < 4 hours (n=66)

Day 10 or ED; >=4 to < 8 hours (n=66)

Day 10 or ED; >=8 to <12 hours (n=66)

Day 10 or ED; >= 12 hours (n=66)

Day 10 or ED; 24 hours (n=66)

Number of Participants With Total Duration of Pain Per Day

Day 1; (n=66)

Mean Number of Rescue Doses

Effective

Ineffective

The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.

Number of Participants With Response Based on Physician's Global Assessment Scale

Overall Study

Spots Global Cancer Trial Database for jns020qd

Every month we try and update this database with for jns020qd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for jns020qd

Every month we try and update this database with for jns020qd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for jns020qd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.