An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 844
- 试验地点
- 1
- 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 long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
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
- None
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
- •Provision of written informed consent prior to any study-specific procedures.
- •NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
- •PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
- •FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 first study visit 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 a risk to the patient.
- •Pregnancy or lactation.
研究组 & 干预措施
1
Oral Treatment
干预措施: NKTR-118 (Drug)
2
Oral treatment
干预措施: Usual care (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
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
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
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
次要结局
未报告次要终点