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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00973024
Other study ID # CR016468
Secondary ID 42160443PAI20032
Status Terminated
Phase Phase 2
First received September 4, 2009
Last updated April 28, 2015
Start date September 2009
Est. completion date May 2011

Study information

Verified date April 2015
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Terminated
Enrollment 389
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in the average low back pain-related pain intensity score At the end of the 12-week double-blind efficacy phase No
Secondary Change from baseline in the ODI subscale and total scores At the end of the 12-week double-blind efficacy phase No
Secondary Change from baseline in the pain severity and pain interference subscales of the BPI Short Form At the end of the 12-week double-blind efficacy phase No
Secondary Changes in PGA scores At the end of the 12-week double-blind efficacy phase No
Secondary Change from baseline in the pain severity and pain interference subscales of the Brief Pain Inventory (BPI) Short Form At the end of the 12-week double-blind efficacy phase No
Secondary Changes in Patient Global Assessment (PGA) scores At the end of the 12-week double-blind efficacy phase No
Secondary Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores At the end of the 12-week double-blind efficacy phase No
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