A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 638
- 试验地点
- 56
- 主要终点
- Number of Participants Reporting Adverse Events
研究概览
简要总结
The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.
详细描述
This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study.
This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-nursing female aged 18 to 75 years old
- •Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months
- •Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
- •Opioid analgesia is necessary
- •Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry
- •Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
- •Willing and able to provide informed consent
排除标准
- •History of hypersensitivity, intolerance, or allergy to opioids
- •Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period
- •Untreated moderate to severe sleep apnea
- •Chronic migraines as the primary pain condition
- •Cancer related pain
研究组 & 干预措施
NKTR-181
NKTR-181 twice daily (BID) tablets
干预措施: NKTR-181 BID tablets (Drug)
结局指标
主要结局
Number of Participants Reporting Adverse Events
时间窗: Screening baseline through end of study, an average of 57 weeks
Count of subjects reporting treatment emergent adverse events
次要结局
- Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52(Baseline, monthly change from baseline till the end of study)
- Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52(Baseline, monthly change from baseline till the end of study)