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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00929188
First received: June 25, 2009
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Pain, Burning
Pain, Crushing
Pain, Migratory
Pain, Radiating
Pain, Splitting
Drug: JNJ-42160443
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Global Impression of Change (PGIC) [ Time Frame: Up to Visit 10 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929188

  Show 40 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00929188     History of Changes
Other Study ID Numbers: CR016057, 42160443PAI2001, 2008-007690-21
Study First Received: June 25, 2009
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines

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:
Burns
Pain
Wounds and Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014