Low Back Pain, Low Back Pain, Recurrent
Conditions
Keywords
JNJ-42160443, Low back pain-related pain, moderate to severe, chronic 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).
Interventions
DRUGJNJ-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.
DRUGJNJ-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.
DRUGJNJ-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.
DRUGJNJ-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.
DRUGMatching Placebo
Form= solution for injection, route= subcutaneous. Matching placebo given as a subcutaneous (SC) (under the skin) injection (inj) once every 4 weeks (wks).
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the average low back pain-related pain intensity score | At the end of the 12-week double-blind efficacy phase |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Changes in PGA scores | At the end of the 12-week double-blind efficacy phase |
| Change from baseline in the ODI subscale and total scores | At the end of the 12-week double-blind efficacy phase |
| Changes in Patient Global Assessment (PGA) scores | At the end of the 12-week double-blind efficacy phase |
| Change from baseline in the Oswestry Disability Index (ODI) subscale and total scores | 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 | At the end of the 12-week double-blind efficacy phase |
Countries
Belgium, Canada, Netherlands, United States
Outcome results
None listed