A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
研究概览
简要总结
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have completed the 12-week study D3820C00004 through Visit
- •Provision of written informed consent prior to any study-specific procedures.
- •Men and women who were between the ages of >18 and <85 years at the time of the screening visit for study D3820C
- •Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.
- •Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (BM) has not occurred within at least 72 hours of the last recorded BM.
排除标准
- •Patients receiving opioid regimen for treatment of pain related to cancer.
- •History of cancer within 5 years from the screening visit of study D3820C00004 with the exception of basal cell cancer and squamous cell skin cancer.
- •Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
- •Other issues related to the gastrointestinal tract that could impose risk to the patient.
- •Pregnancy or lactation.
研究组 & 干预措施
NKTR-118 12.5mg
干预措施: NKTR-118 (Drug)
NKTR-118 25mg
干预措施: NKTR-118 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
时间窗: Baseline (Week 0) to end of the follow-up period (Week 14)
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Incidence of Patients Experiencing at Least One Adverse Event (AE)
时间窗: Baseline (Week 0) to end of the follow-up period (Week 14)
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
时间窗: Baseline (Week 0) to end of the follow-up period (Week 14)
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
次要结局
- Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)(Baseline (prior to treatment) to last on-treatment assessment (up to Week 12))
- Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)(Baseline (prior to treatment) to last on-treatment assessment (up to Week 12))