A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain
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
3 other identifiers
interventional
100
5 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2009
Longer than P75 for phase_2
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJanuary 22, 2016
December 1, 2015
5.3 years
June 25, 2009
December 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in the average cancer-related pain intensity score.
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 Outcomes (1)
Patient Global Impression of Change (PGIC)
Up to Visit 10
Study Arms (2)
001
EXPERIMENTALJNJ-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
002
PLACEBO COMPARATORPlacebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
Interventions
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
Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Montebello, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Stockbridge, Georgia, United States
Unknown Facility
Anderson, Indiana, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Marrero, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Farmington Hills, Michigan, United States
Unknown Facility
Flat Rock, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Orem, Utah, United States
Unknown Facility
Falls Church, Virginia, United States
Unknown Facility
Lille, France
Unknown Facility
Lyon, France
Unknown Facility
Suresnes, France
Unknown Facility
Toulouse, France
Unknown Facility
Villejuif, France
Unknown Facility
Bygdoszcz, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Gdansk-Zaspa, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Almada, Portugal
Unknown Facility
Coimbra, Portugal
Unknown Facility
Faro, Portugal
Unknown Facility
Lisbon, Portugal
Unknown Facility
Ponta Delgada, Portugal
Unknown Facility
Porto, Portugal
Unknown Facility
Setúbal, Portugal
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Palma de Mallorca, Spain
Unknown Facility
San Sebastián de los Reyes, Spain
Unknown Facility
Terrasa Barcelona N/A, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
January 22, 2016
Record last verified: 2015-12