A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain

Johnson & Johnson (J&J)

Status and phase: Terminated; Phase 2

Conditions: Low Back Pain, Recurrent; Low Back Pain

Treatments: Drug: JNJ-42160443 6 mg/3mg; Drug: JNJ-42160443 1 mg; Drug: JNJ-42160443 10 mg; Drug: JNJ-42160443 3 mg; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00973024

2009-009857-17 (EudraCT Number)

CR016468

42160443PAI2003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe low back pain patients with a diagnosis of chronic low back pain.

Full 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 different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of chronic low back pain who have moderate to severe, chronic low back pain that is not controlled by standard pain medications. JNJ-42160443 (10 mg/ml) or matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks); one of four JNJ-42160443 doses (1 mg every 4 wks; 3 mg every 4 wks; 6 mg loading dose on Day 1 followed by 3 mg every 4 wks; or 10 mg every 4 wks, or matching placebo for up to 104 wks (12-wk double-blind efficacy period + 92-wk double-blind extension period).

Enrollment: 389 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic low back pain

Exclusion criteria

• Pain with radiation to the extremity and with neurologic signs
• history within the past year of any of the following: seizure disorder
• intrathecal therapy and ventricular shunts, mild or moderate traumatic brain injury, stroke, or transient ischemic attack, meningitis
• History of brain injury within the past 15 years consisting of >= 1 of the following, or with residual sequalae suggesting transient changes in consciousness: brain contusion, intracranial hematoma, either unconsciousness or posttraumatic amnesia lasting more than 24 hours
• History of epilepsy or multiple sclerosis
• Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equine compression, back pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm
• Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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389 participants in 4 patient groups

JNJ-42160443 1 mg

Experimental group

Treatment:

Drug: Matching Placebo

Drug: JNJ-42160443 1 mg

JNJ-42160443 3 mg

Experimental group

Treatment:

Drug: Matching Placebo

Drug: JNJ-42160443 3 mg

JNJ-42160443 6 mg/3mg

Experimental group

Treatment:

Drug: Matching Placebo

Drug: JNJ-42160443 6 mg/3mg

JNJ-42160443 10 mg

Experimental group

Treatment:

Drug: Matching Placebo

Drug: JNJ-42160443 10 mg