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A Study of JNS020QD in Patients With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
JNS020QD
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, JNS020QD, Fentanyl, Opioid analgesics

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic pain that requires opioid analgesics and that has persisted for 12 weeks or longer before giving the consent
  • Patients who received any of the following opioid analgesics at a stable dose for the treatment of chronic pain for 7 days or longer before giving the consent (excluding rescue dose): oral codeine phosphate; oral morphine hydrochloride; fentanyl transdermal; combination tablet of tramadol hydrochloride and acetaminophen; buprenorphine transdermal patch
  • Patients who received 2 or less rescue doses per day during the 7 days before giving consent
  • Patients whose mean pain intensity throughout the day of giving the consent is 45 mm or less on the visual analogue scale (VAS)
  • Male and female patients surgically sterile, abstinent, or practicing an effective method of birth control. Female patients have a negative pregnancy test result at screening. Male patients cannot donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

  • Other painful conditions which may interfere with the efficacy evaluation (eg bone fracture, rheumatoid arthritis)
  • Major surgery within 30 days before screening, or not fully recovered from surgery, or planned surgery during the time of the study
  • Pain that is considered mainly psychogenic
  • Uncontrolled/clinically significant arrhythmia
  • Hepatic function disorder such as fulminant hepatitis and hepatic cirrhosis, or renal impairment such as nephritic syndrome, acute or chronic renal failure
  • Any other condition that, in the opinion of the investigator, would compromise the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JNS020QD

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients who maintained the adequate analgesia
Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.

Secondary Outcome Measures

Proportion of patients who achieve dose-adjustment
Criteria for achievement of dose-adjustment is defined as: 1) The daily dose of the study drug is constant during the 3 days before completion of the titration period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 3 days in the titration period is ≤2 doses; 4) daily doses of the study drug during the titration period does not exceed the maximum doses stipulated by the investigators.

Full Information

First Posted
December 8, 2011
Last Updated
March 21, 2014
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT01493245
Brief Title
A Study of JNS020QD in Patients With Chronic Pain
Official Title
A Phase 3 Study of JNS020QD in Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who switched from opioid analgesics, as well as the safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD.
Detailed Description
The primary objective of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who are switching from opioid analgesics. It will also evaluate the safety and efficacy of long-term treatment (52 weeks) after switching to JNS020QD. The study will enroll patients with moderate to severe chronic pain which is adequately controlled with a regular treatment with an opioid analgesic agent other than the study drug because these patients are considered appropriate to investigate the conversion ratio in switching from JNS020QD to other opioid analgesics, and to evaluate the efficacy and safety of the study drug. This is an open-label (all people know the identity of the intervention), uncontrolled (the study does not involve a control treatment), multicenter study. This study consists of Screening period (1 to 2 weeks), Period I (3-week titration period+ 1-week maintenance period), Period II (48 weeks long-term treatment period), tapering period (if required, 0 to 6 weeks), and follow-up period (1 week). JNS020QD is a transdermal system in which fentanyl base is incorporated directly into a single layer of pressure-sensitive high polymerized adhesive, and is changed once a day (every 24 hours). JNS020QD is available in 5 formulations containing fentanyl 0.84 mg, 1.7 mg, 3.4 mg, 5 mg, or 6.7 mg per system.. The study drug patch will be applied to the breast, abdomen, upper arm, femoral region, etc. exchanged daily and for consecutive 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, JNS020QD, Fentanyl, Opioid analgesics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNS020QD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JNS020QD
Intervention Description
During weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks.
Primary Outcome Measure Information:
Title
Proportion of patients who maintained the adequate analgesia
Description
Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.
Time Frame
At Week 4
Secondary Outcome Measure Information:
Title
Proportion of patients who achieve dose-adjustment
Description
Criteria for achievement of dose-adjustment is defined as: 1) The daily dose of the study drug is constant during the 3 days before completion of the titration period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 3 days in the titration period is ≤2 doses; 4) daily doses of the study drug during the titration period does not exceed the maximum doses stipulated by the investigators.
Time Frame
Days 19-21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic pain that requires opioid analgesics and that has persisted for 12 weeks or longer before giving the consent Patients who received any of the following opioid analgesics at a stable dose for the treatment of chronic pain for 7 days or longer before giving the consent (excluding rescue dose): oral codeine phosphate; oral morphine hydrochloride; fentanyl transdermal; combination tablet of tramadol hydrochloride and acetaminophen; buprenorphine transdermal patch Patients who received 2 or less rescue doses per day during the 7 days before giving consent Patients whose mean pain intensity throughout the day of giving the consent is 45 mm or less on the visual analogue scale (VAS) Male and female patients surgically sterile, abstinent, or practicing an effective method of birth control. Female patients have a negative pregnancy test result at screening. Male patients cannot donate sperm during the study and for 3 months after receiving the last dose of study drug Exclusion Criteria: Other painful conditions which may interfere with the efficacy evaluation (eg bone fracture, rheumatoid arthritis) Major surgery within 30 days before screening, or not fully recovered from surgery, or planned surgery during the time of the study Pain that is considered mainly psychogenic Uncontrolled/clinically significant arrhythmia Hepatic function disorder such as fulminant hepatitis and hepatic cirrhosis, or renal impairment such as nephritic syndrome, acute or chronic renal failure Any other condition that, in the opinion of the investigator, would compromise the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Asahikawa
Country
Japan
City
Chiba
Country
Japan
City
Isesaki
Country
Japan
City
Izumo
Country
Japan
City
Kawasaki N/A
Country
Japan
City
Kobe
Country
Japan
City
Matsumoto
Country
Japan
City
Nishinomiya
Country
Japan
City
Ohtsu
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Sagamihara
Country
Japan
City
Saga
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Toyama
Country
Japan
City
Yamagata
Country
Japan
City
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3333&filename=CR018745_CSR.pdf
Description
A Phase 3 Study of JNS020QD in Patients with Chronic Pain

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A Study of JNS020QD in Patients With Chronic Pain

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