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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00641667
First received: March 17, 2008
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Pain
Cancer
Drug: Fentanyl
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Percentage of Participants Achieving Pain Control [ Time Frame: Day 10 or early discontinuation (ED) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Response Based on Patient's Global Assessment Scale [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Visual Analog Scale (VAS) Score [ Time Frame: Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED ] [ Designated as safety issue: No ]
    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".

  • Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Total Duration of Pain Per Day [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED ] [ Designated as safety issue: No ]
    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).

  • Mean Number of Rescue Doses [ Time Frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Response Based on Physician's Global Assessment Scale [ Time Frame: Day 10 or ED ] [ Designated as safety issue: No ]
    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.


Enrollment: 66
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl Drug: Fentanyl
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).
Other Name: JNS020QD

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641667

Locations
Japan
Kitakyushu, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00641667     History of Changes
Other Study ID Numbers: CR014896, JNS020QD-JPN-C01
Study First Received: March 17, 2008
Results First Received: March 21, 2013
Last Updated: May 31, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Pain
Cancer
Fentanyl
JNS020QD

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014