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JNJ-42160443

Phase 2

Pain, Burning | Small molecule | Pain |Johnson & Johnson|Last Updated: Jan 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-42160443 · 1 trial · 5 indications

Phase 2 1
NCT00929188A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related PainPain, Burning
COMPLETED100 Analytics
PHASE2COMPLETED
A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain
Pain, BurningUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Patient Global Impression of Change (PGIC)
Up to Visit 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALJNJ-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
002PLACEBO_COMPARATORPlacebo Form=solution for injection route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1

Interventions

NameTypeDescription
JNJ-42160443DRUGType=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
PlaceboDRUGForm=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites40

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 sta...

Countries:United StatesFrancePolandPortugalSpain
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Frequently asked questions about JNJ-42160443

What is JNJ-42160443 used for?

JNJ-42160443 is an investigational small molecule being studied for the treatment of pain, including burning, crushing, migratory, radiating, and splitting pain. It is being evaluated as an add-on treatment in patients with cancer-related pain. The drug is currently in Phase 2 clinical development.

Who makes JNJ-42160443?

JNJ-42160443 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational small molecule in Phase 2 clinical development for the treatment of pain.

What phase is JNJ-42160443 in?

JNJ-42160443 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial studying the drug as an add-on treatment for cancer-related pain has been completed.

What clinical trials is JNJ-42160443 in?

JNJ-42160443 has one completed Phase 2 clinical trial, identified as NCT00929188. This study evaluated the safety and effectiveness of JNJ-42160443 as an add-on treatment in patients with cancer-related pain. The trial enrolled 100 participants and was conducted in the United States, France, Poland, Portugal, and Spain.

Is JNJ-42160443 the same as another drug?

JNJ-42160443 is the drug name used in clinical trials. No alternative names have been reported for this investigational compound. It is being developed by Johnson & Johnson for the treatment of pain.