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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

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ClinicalTrials.gov Identifier: NCT00973024
Recruitment Status : Terminated (Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.)
First Posted : September 9, 2009
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE September 4, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
  • Change from baseline in the ODI subscale and total scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ]
  • 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 ]
  • Changes in PGA scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ]
  • 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 ]
  • Changes in Patient Global Assessment (PGA) scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
  • Change from baseline in the ODI subscale and total scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ]
  • 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 ]
  • Changes in PGA scores [ Time Frame: At the end of the 12-week double-blind efficacy phase ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Low Back Pain, Recurrent
Intervention  ICMJE
  • 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: 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: 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: 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).
Study Arms  ICMJE
  • Experimental: JNJ-42160443 1 mg
    Interventions:
    • Drug: JNJ-42160443 1 mg
    • Drug: Matching Placebo
  • Experimental: JNJ-42160443 3 mg
    Interventions:
    • Drug: JNJ-42160443 3 mg
    • Drug: Matching Placebo
  • Experimental: JNJ-42160443 6 mg/3mg
    Interventions:
    • Drug: JNJ-42160443 6 mg/3mg
    • Drug: Matching Placebo
  • Experimental: JNJ-42160443 10 mg
    Interventions:
    • Drug: JNJ-42160443 10 mg
    • Drug: Matching Placebo
Publications * Sanga P, Polverejan E, Wang S, Kelly KM, Thipphawong J. Efficacy, Safety, and Tolerability of Fulranumab as an Adjunctive Therapy in Patients With Inadequately Controlled, Moderate-to-Severe Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Dose-loading Phase II Study. Clin Ther. 2016 Jun;38(6):1435-1450. doi: 10.1016/j.clinthera.2016.03.030. Epub 2016 Apr 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 25, 2011)
389
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2009)
360
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973024
Other Study ID Numbers  ICMJE CR016468
42160443PAI2003 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
2009-009857-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP