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

Purpose

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.

Condition	Intervention	Phase
Low Back Pain Low Back Pain, Recurrent	Drug: JNJ-42160443 3 mg Drug: JNJ-42160443 1 mg Drug: JNJ-42160443 6 mg/3mg Drug: JNJ-42160443 10 mg Drug: Matching Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Chronic Pain

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Change from baseline in the average low back pain-related pain intensity score [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the ODI subscale and total scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Change from baseline in the pain severity and pain interference subscales of the BPI Short Form [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Changes in PGA scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Changes in Patient Global Assessment (PGA) scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]
Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ] [ Designated as safety issue: No ]

Enrollment:	389
Study Start Date:	September 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: JNJ-42160443 1 mg	Drug: JNJ-42160443 1 mg 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. Drug: Matching Placebo Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
Experimental: JNJ-42160443 3 mg	Drug: JNJ-42160443 3 mg 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. Drug: Matching Placebo Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
Experimental: JNJ-42160443 6 mg/3mg	Drug: JNJ-42160443 6 mg/3mg 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. Drug: Matching Placebo Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
Experimental: JNJ-42160443 10 mg	Drug: JNJ-42160443 10 mg 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. Drug: Matching Placebo Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).

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).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973024

Show 58 Study Locations

Sponsors and Collaborators

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

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial

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

More Information

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00973024 History of Changes
Other Study ID Numbers:	CR016468, 42160443PAI2003, 2009-009857-17
Study First Received:	September 4, 2009
Last Updated:	August 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013