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

Pain, Radiating Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929188
• Other study ID #: CR016057
• Secondary ID: 42160443PAI20012
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2009
• Last updated: December 18, 2015
• Start date: October 2009
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  France,  Poland,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Patient Global Impression of Change (PGIC)		Up to Visit 10	No