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

Primary Purpose

Low Back Pain, Low Back Pain, Recurrent

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

JNJ-42160443 3 mg

JNJ-42160443 1 mg

JNJ-42160443 6 mg/3mg

JNJ-42160443 10 mg

Matching Placebo

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring JNJ-42160443, Low back pain-related pain, moderate to severe, chronic pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

JNJ-42160443 1 mg

JNJ-42160443 3 mg

JNJ-42160443 6 mg/3mg

JNJ-42160443 10 mg

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the average low back pain-related pain intensity score

Secondary Outcome Measures

Change from baseline in the ODI subscale and total scores

Change from baseline in the pain severity and pain interference subscales of the BPI Short Form

Changes in PGA scores

Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form

Changes in Patient Global Assessment (PGA) scores

Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores

Full Information

NCT ID

NCT00973024

First Posted

September 4, 2009

Last Updated

May 23, 2016

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00973024

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Low Back Pain, Recurrent

Keywords

JNJ-42160443, Low back pain-related pain, moderate to severe, chronic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

389 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JNJ-42160443 1 mg

Arm Type

Experimental

Arm Title

JNJ-42160443 3 mg

Arm Type

Experimental

Arm Title

JNJ-42160443 6 mg/3mg

Arm Type

Experimental

Arm Title

JNJ-42160443 10 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

JNJ-42160443 3 mg

Intervention Description

JNJ-42160443: type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 3 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.

Intervention Type

Drug

Intervention Name(s)

JNJ-42160443 1 mg

Intervention Description

JNJ-42160443: type=exact number, unit=mg, number= 1, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 1 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.

Intervention Type

Drug

Intervention Name(s)

JNJ-42160443 6 mg/3mg

Intervention Description

JNJ-42160443: type= exact number, unit= mg, number= 3 and 6, form=solution for injection, route= Subcutaneous use or Placebo: form= solution for injection, route= Subcutaneous injection. 1 inj of 6 mg of JNJ-42160443 on Day 1 followed by 1 inj of 3 mg or matching placebo every 4 wks for up to 104 wks.

Intervention Type

Drug

Intervention Name(s)

JNJ-42160443 10 mg

Intervention Description

JNJ-42160443 10 mg: type=exact number, unit=mg, number= 10, form=solution for injection, route=Subcutaneous use or Placebo: form=solution for injection, route=Subcutaneous injection. One inj of 10 mg of JNJ-42160443 or matching placebo every 4 wks for up to 104 wks.

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Intervention Description

Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).

Primary Outcome Measure Information:

Title

Change from baseline in the average low back pain-related pain intensity score

Time Frame