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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00929188
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain, Burning Pain, Crushing Pain, Migratory Pain, Radiating Pain, Splitting Drug: JNJ-42160443 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 001
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
 Drug: 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 Comparator: 002
Placebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
 Drug: Placebo
Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Patient Global Impression of Change (PGIC) [ Time Frame: Up to Visit 10 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929188


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Laguna Hills, California, United States
Montebello, California, United States
San Diego, California, United States
United States, Florida
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Stockbridge, Georgia, United States
United States, Indiana
Anderson, Indiana, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Marrero, Louisiana, United States
Shreveport, Louisiana, United States
United States, Michigan
Farmington Hills, Michigan, United States
United States, North Carolina
Flat Rock, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Utah
Orem, Utah, United States
United States, Virginia
Falls Church, Virginia, United States
France
Lille, France
Lyon, France
Suresnes, France
Toulouse, France
Villejuif, France
Poland
Bygdoszcz, Poland
Gdansk-Zaspa, Poland
Gdansk, Poland
Lodz, Poland
Warszawa, Poland
Wroclaw, Poland
Portugal
Almada N/A, Portugal
Coimbra, Portugal
Faro, Portugal
Lisboa, Portugal
Ponta Delgada, Portugal
Porto, Portugal
Setubal, Portugal
Spain
Barcelona N/A, Spain
Madrid, Spain
Palma De Mallorca, Spain
San Sebastián De Los Reyes, Spain
Terrasa Barcelona N/A, Spain
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00929188    
Other Study ID Numbers: CR016057
42160443PAI2001 ( Other Identifier: Janssen Research & Development, LLC )
2008-007690-21 ( EudraCT Number )
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: December 2015
Keywords provided by Janssen Research & Development, LLC:
Moderate to severe chronic, cancer-related pain related to an active cancer
Cancer-related pain
Moderate to severe chronic pain
JNJ-42160443
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations