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

This study has been terminated.
(Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00973024
First received: September 4, 2009
Last updated: August 21, 2012
Last verified: August 2012
  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:


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 April 17, 2014