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

• ClinicalTrials.gov Identifier: NCT00929188
• Recruitment Status: Completed
• First Posted: June 26, 2009
• Last Update Posted: January 22, 2016
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: June 25, 2009
• First Posted Date: June 26, 2009
• Last Update Posted Date: January 22, 2016
• Study Start Date: October 2009
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 23, 2011): 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) ]
• Original Primary Outcome Measures (submitted: June 25, 2009): The primary outcome measure is 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) ]
• Current Secondary Outcome Measures (submitted: August 23, 2011): Patient Global Impression of Change (PGIC) [ Time Frame: Up to Visit 10 ]

Original Secondary Outcome Measures (submitted: June 25, 2009)

• Change in pain intensity and interference item scores of the BPI Short Form [ Time Frame: End of Week 4 ]
• PGIC and CGIC results [ Time Frame: At Visits 4, 6, 8, 10 ]
• Change in "how much pain you have right now" scores [ Time Frame: End of Week 4 ]
• Change in "pain at its worst in the past 24 hours" [ Time Frame: End of Week 4 ]
• Change in total opioid use [ Time Frame: End of Week 4 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Pain, Burning
• Pain, Crushing
• Pain, Migratory
• Pain, Radiating
• Pain, Splitting

Intervention

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

Study Arms

• 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
  Intervention: Drug: JNJ-42160443
• Placebo Comparator: 002
  Placebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 16, 2014): 100
• Original Estimated Enrollment (submitted: June 25, 2009): 90
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Poland, Portugal, Spain, United States
• Removed Location Countries: Belgium, Netherlands

Administrative Information

• NCT Number: NCT00929188
• Other Study ID Numbers: CR016057; 42160443PAI2001 ( Other Identifier: Janssen Research & Development, LLC ); 2008-007690-21 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Janssen Research & Development, LLC
• Original Responsible Party: Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
• Current Study Sponsor: Janssen Research & Development, LLC
• Original Study Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

• PRS Account: Janssen Research & Development, LLC
• Verification Date: December 2015