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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 389
- 主要终点
- Change from baseline in the average low back pain-related pain intensity score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic low back pain
排除标准
- •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
研究组 & 干预措施
JNJ-42160443 10 mg
干预措施: Matching Placebo (Drug)
JNJ-42160443 1 mg
干预措施: JNJ-42160443 1 mg (Drug)
JNJ-42160443 1 mg
干预措施: Matching Placebo (Drug)
JNJ-42160443 3 mg
干预措施: JNJ-42160443 3 mg (Drug)
JNJ-42160443 3 mg
干预措施: Matching Placebo (Drug)
JNJ-42160443 6 mg/3mg
干预措施: JNJ-42160443 6 mg/3mg (Drug)
JNJ-42160443 6 mg/3mg
干预措施: Matching Placebo (Drug)
JNJ-42160443 10 mg
干预措施: JNJ-42160443 10 mg (Drug)
结局指标
主要结局
Change from baseline in the average low back pain-related pain intensity score
时间窗: At the end of the 12-week double-blind efficacy phase
次要结局
- 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)
- Changes in PGA 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)
- 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 BPI Short Form(At the end of the 12-week double-blind efficacy phase)