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

NCT ID: NCT00929188

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-01-31

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.

Conditions

Pain, Burning; Pain, Crushing; Pain, Migratory; Pain, Radiating; Pain, Splitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

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

002

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Birmingham, Alabama, United States

Tucson, Arizona, United States

Laguna Hills, California, United States

Montebello, California, United States

San Diego, California, United States

Miami, Florida, United States

Orlando, Florida, United States

Stockbridge, Georgia, United States

Anderson, Indiana, United States

Lexington, Kentucky, United States

Marrero, Louisiana, United States

Shreveport, Louisiana, United States

Farmington Hills, Michigan, United States

Flat Rock, North Carolina, United States

Cleveland, Ohio, United States

Orem, Utah, United States

Falls Church, Virginia, United States

Lille, , France

Lyon, , France

Suresnes, , France

Toulouse, , France

Villejuif, , France

Bygdoszcz, , Poland

Gdansk, , Poland

Gdansk-Zaspa, , Poland

Lodz, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Almada, , Portugal

Coimbra, , Portugal

Faro, , Portugal

Lisbon, , Portugal

Ponta Delgada, , Portugal

Porto, , Portugal

Setúbal, , Portugal

Barcelona, , Spain

Madrid, , Spain

Palma de Mallorca, , Spain

San Sebastián de los Reyes, , Spain

Terrasa Barcelona N/A, , Spain

Countries

United States; France; Poland; Portugal; Spain

Other Identifiers

42160443PAI2001

Identifier Type: OTHER

Identifier Source: secondary_id

2008-007690-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016057

Identifier Type: -

Identifier Source: org_study_id