A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 207
- 试验地点
- 33
- 主要终点
- Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
研究概览
简要总结
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older, male or female
- •Receiving a stable opioid regimen
- •Documented opioid-induced constipation
- •Willingness to stop all laxatives and other bowel regimens. The use of constipation rescue medication will be allowed during the study.
排除标准
- •Life expectancy less than 6 months
- •Active substance abuse
- •Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea or intermittent loose stools or constipation
- •Pregnant or breast-feeding
- •Any receipt of an investigational medication within 30 days of screening
- •History or presence of specific cardiac, neurologic, endocrine and/or psychiatric conditions
研究组 & 干预措施
A
Placebo
干预措施: placebo (Drug)
B
NKTR-118
干预措施: NKTR-118 (Drug)
结局指标
主要结局
Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
时间窗: Days 1 through 7
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
次要结局
- Change From Baseline in SBMs/Week Across the 28-day Double-blind Period(Days 1 through 28)
- Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire(Days 1 through 28)
- Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire(Days 1 through 28)