A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening
- •Must have active OIC at screening
- •Active OIC must be confirmed during baseline screening bowel habit and symptom diary
- •Must be on stable diet
排除标准
- •Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)
- •Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
- •Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
- •Unstable thyroid disease
研究组 & 干预措施
SP-333 1 mg
1 mg SP-333 orally once daily for 4-week Treatment Period
干预措施: SP-333 1 mg (Drug)
SP-333 3 mg
3 mg SP-333 orally once daily for 4-week Treatment Period
干预措施: SP-333 3 mg (Drug)
SP-333 6 mg
6 mg SP-333 orally once daily for 4-week Treatment Period
干预措施: SP-333 6 mg (Drug)
Placebo
Placebo orally once daily for 4-week Treatment Period
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
时间窗: 4 Weeks
Compare SP-333 (1, 3 \& 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
次要结局
- To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC(4 weeks)