Clinical trial NCT00929188: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Burning
Pain, Crushing
Pain, Migratory
Pain, Radiating
Pain, Splitting
Keywords: Moderate to severe chronic, cancer-related pain related to an active cancer
Cancer-related pain
Moderate to severe chronic pain
JNJ-42160443
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in the average cancer-related pain intensity score.
timeFrame: 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:
measure: Patient Global Impression of Change (PGIC)
timeFrame: Up to Visit 10
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Laguna Hills
country: United States
state: California
city: Montebello
country: United States
state: California
city: San Diego
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Anderson
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Farmington Hills
country: United States
state: Michigan
city: Flat Rock
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Orem
country: United States
state: Utah
city: Falls Church
country: United States
state: Virginia
city: Lille
country: France
city: Lyon
country: France
city: Suresnes
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Bygdoszcz
country: Poland
city: Gdansk-Zaspa
country: Poland
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Almada N/A
country: Portugal
city: Coimbra
country: Portugal
city: Faro
country: Portugal
city: Lisboa
country: Portugal
city: Ponta Delgada
country: Portugal
city: Porto
country: Portugal
city: Setubal
country: Portugal
city: Barcelona N/A
country: Spain
city: Madrid
country: Spain
city: Palma De Mallorca
country: Spain
city: San Sebastián De Los Reyes
country: Spain
city: Terrasa Barcelona N/A
country: Spain
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: