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A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain

Primary Purpose

Pain, Burning, Pain, Crushing, Pain, Migratory

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-42160443
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Burning focused on measuring Moderate to severe chronic, cancer-related pain related to an active cancer, Cancer-related pain, Moderate to severe chronic pain, JNJ-42160443

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Terminally ill cancer patients as per judgment of the investigator (eg, patients who are in or who are candidates for hospice or palliative care for end-of-life management); Diagnosis of moderate to severe pain directly related to an active cancer that is not controlled by standard pain treatments.

Exclusion Criteria:Planned major surgical procedures during the double-blind treatment phase that may affect study outcomes; Prior treatment with any other investigational NGF inhibitor therapy; Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its excipients; Enrolled in any investigational study within the previous 4 weeks or 5 half-lives of the investigational drug (whichever is longer), or are currently enrolled in another investigational study at the time of screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

001

002

Arm Description

JNJ-42160443 Type=1 unit=mg number=10 form=solution for injection route=subcutaneous use. SC injection (10mg/ml) once every 4 weeks for up to 52 weeks

Placebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1

Outcomes

Primary Outcome Measures

The change in the average cancer-related pain intensity score.

Secondary Outcome Measures

Patient Global Impression of Change (PGIC)

Full Information

First Posted
June 25, 2009
Last Updated
December 18, 2015
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00929188
Brief Title
A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill patients with a diagnosis of active cancer.
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of JNJ-42160443 compared with placebo in the treatment of men and women 18 years of age or older who are terminally ill (ie, patients who are in or who are candidates for hospice or palliative [other medical care] care for end-of-life management) with moderate to severe, chronic, cancer-related pain that is not controlled by standard pain medications and who have a diagnosis of active cancer. The duration of the study will be approximately 62 weeks (includes screening, the 4-week double-blind phase followed by the 48-week open-label [study doctor and patient knows the name of the assigned treatment] extension phase and a posttreatment phase). A single dose of JNJ-42160443 or matching placebo given as an (subcutaneous [SC]) injection under the skin during the double-blind treatment period. During the open-label period, JNJ-42160443 will be given once every 4 weeks for up to 48 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burning, Pain, Crushing, Pain, Migratory, Pain, Radiating, Pain, Splitting
Keywords
Moderate to severe chronic, cancer-related pain related to an active cancer, Cancer-related pain, Moderate to severe chronic pain, JNJ-42160443

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
001
Arm Type
Experimental
Arm Description
JNJ-42160443 Type=1 unit=mg number=10 form=solution for injection route=subcutaneous use. SC injection (10mg/ml) once every 4 weeks for up to 52 weeks
Arm Title
002
Arm Type
Placebo Comparator
Arm Description
Placebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
Intervention Type
Drug
Intervention Name(s)
JNJ-42160443
Intervention Description
Type=1, unit=mg, number=10, form=solution for injection , route=subcutaneous use. SC injection (10mg/ml) once every 4 weeks for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
Primary Outcome Measure Information:
Title
The change in the average cancer-related pain intensity score.
Time Frame
From baseline (average cancer-related pain intensity score over the last 3 days before randomization) to the end of Week 4 (average cancer-related pain intensity score over the last 7 days of the double-blind treatment phase)
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC)
Time Frame
Up to Visit 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Terminally ill cancer patients as per judgment of the investigator (eg, patients who are in or who are candidates for hospice or palliative care for end-of-life management); Diagnosis of moderate to severe pain directly related to an active cancer that is not controlled by standard pain treatments. Exclusion Criteria:Planned major surgical procedures during the double-blind treatment phase that may affect study outcomes; Prior treatment with any other investigational NGF inhibitor therapy; Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its excipients; Enrolled in any investigational study within the previous 4 weeks or 5 half-lives of the investigational drug (whichever is longer), or are currently enrolled in another investigational study at the time of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
City
Montebello
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Stockbridge
State/Province
Georgia
Country
United States
City
Anderson
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Marrero
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Farmington Hills
State/Province
Michigan
Country
United States
City
Flat Rock
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Orem
State/Province
Utah
Country
United States
City
Falls Church
State/Province
Virginia
Country
United States
City
Lille
Country
France
City
Lyon
Country
France
City
Suresnes
Country
France
City
Toulouse
Country
France
City
Villejuif
Country
France
City
Bygdoszcz
Country
Poland
City
Gdansk-Zaspa
Country
Poland
City
Gdansk
Country
Poland
City
Lodz
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Almada N/A
Country
Portugal
City
Coimbra
Country
Portugal
City
Faro
Country
Portugal
City
Lisboa
Country
Portugal
City
Ponta Delgada
Country
Portugal
City
Porto
Country
Portugal
City
Setubal
Country
Portugal
City
Barcelona N/A
Country
Spain
City
Madrid
Country
Spain
City
Palma De Mallorca
Country
Spain
City
San Sebastián De Los Reyes
Country
Spain
City
Terrasa Barcelona N/A
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain

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