An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Naïve Patients With Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 62
- 主要终点
- Change in pain intensity from baseline (pre-randomization) to last assessment.
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.
详细描述
Patients with low back pain who are sub-optimally responsive to their current analgesic treatment begin open-label treatment with oxymorphone extended release (ER). During the Open-Label Titration Period, patients will receive daily oxymorphone ER by mouth (PO) q12h. The investigator will initiate the Open-Label Titration Period using study drug at a dose of 5 mg PO q12h for 2 days; thereafter, patients will continue receiving 5 mg q12h or be titrated at increments of 5-10 mg q12h every 3-7 days until stabilization is achieved. The goal of the Open-Label Titration Period is to determine for each patient a fixed dose of study medication that is tolerated and achieves adequate analgesia. Stabilized patients will be randomiozed to either continue with current dose of oxymorphone ER or receive placebo for a total duration of 12 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 years of age or older
- •opioid naïve
- •Have an initial pain intensity score of at least 50 mm VAS
- •In good health as determined by the investigator on the basis of medical history and physical examination
- •Have moderate to severe chronic non-neuropathic LBP that has been present daily for at least several hours per day for a minimum of three months prior to the Screening
- •Any adjunct therapy for back pain such as physical therapy, biofeedback therapy, acupuncture therapy or herbal remedies, based on the patient's current status should remain unchanged during the period of participation of the patient
- •Written informed consent
排除标准
- •Pregnant and/or lactating
- •Radiculopathy, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, severe lower extremity weakness or numbness, bowel or bladder dysfunction secondary to cauda equina compression, diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection or tumor
- •Cannot or will not agree to stop local regional pain treatments during the study (nerve/plexus blocks or ablation, neurosurgical procedures for pain control, or inhalation analgesia). The patient must not have a nerve/plexus block within 4 weeks of screening
- •Intend to alter physical therapy regimen during the study.
- •Surgical procedures directed towards the source of back pain within 6 months of screening
- •Pain which is secondary to confirmed or suspected neoplasm
- •Dysphagia or difficulty swallowing tablets or capsules, or an inability to take oral medication
- •Significant prior history of substance abuse or alcohol abuse
- •Use of any investigational medication within 30 days prior to the first dose of study medication
- •Previous exposure to oxymorphone
- •History of clinically significant intolerance to oxymorphone or a known hypersensitivity to opioid analgesics
- •History of seizure
- •Ileostomy or colostomy
- •Use of MAO inhibitor within 14 days prior to the start of study medication
- •Other clinically significant conditions as judged by the investigator
结局指标
主要结局
Change in pain intensity from baseline (pre-randomization) to last assessment.
次要结局
- Time to early discontinuation due to lack of efficacy
- Patient's Global Assessment of Pain Medication
- Safety as measured by AEs
- Physician's Global Assessment of Pain Medication