NCT01755546已完成3 期
A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time
BioDelivery Sciences International56 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 56
- 主要终点
- Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
研究概览
简要总结
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Female subjects who are practicing abstinence or using a medically acceptable form of contraception or have been postmenopausal, biologically sterile, or surgically sterile for more than 1 year
- •Male subjects who are practicing abstinence, surgically sterile, or are using a medically acceptable form of contraception
- •De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP (eg, CLBP, OA, neuropathic pain) for ≥ 3 months
- •De Novo subject that is treating their CP with a stable daily maintenance dose of ATC opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate Equivalent (MSE) per day for ≥ 4 weeks
- •Stable health, as determined by the Principal Investigator
- •Subject is willing and able to comply with all protocol required visits and assessments
- •Rollover subject who has completed the 12-week Double-blind Treatment Phase in the EN3409-307/308 clinical study
排除标准
- •A history or current evidence of any clinically significant disorder or any other condition, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •Females who are pregnant, breastfeeding, or plan to become pregnant during the study
- •Current cancer-related pain or received chemotherapy within 6 months of screening
- •Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of screening
- •De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per day within 28 days of screening
- •Subjects with a history of other chronic painful conditions, other than the index CP condition, which require frequent analgesic medication
- •Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
- •History of allergy or contraindications to any opioid or acetaminophen
- •Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28 days of screening
- •Hypokalemia or clinically unstable cardiac disease
- •Moderate to severe hepatic impairment
- •Moderate to severe renal impairment
- •Current or past history of alcohol or substance
- •Positive urine toxicology screen for drugs of abuse
- •History of abnormalities on physical exam, vital signs, ECG, or lab values
研究组 & 干预措施
EN3409
Experimental
Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily
干预措施: EN3409 (Drug)
结局指标
主要结局
Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score
时间窗: 48 weeks
The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.
次要结局
未报告次要终点
研究者
研究点 (56)
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