NCT02246816撤回3 期
A Phase 3, Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
MP-101 will be evaluated in this study to see if it is safe and tolerable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female adults, 18 years of age or older
- •Have SBS that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies
- •Must have been deemed a completer of study protocol MP-101-CL-
- •Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months of natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy)
- •Females of childbearing potential must agree to use 1 of the following acceptable birth control methods:
- •Surgically sterile (hysterectomy or bilateral oophorectomy)
- •Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)
- •Intrauterine device (IUD) in place for at least 3 months
- •Abstinence (not having sexual intercourse)
- •Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion
- •Stable hormonal contraceptive for at least 3 months prior to study and through study completion
- •Vasectomized partner
- •Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Visit
- •Be able to understand and provide signed informed consent
排除标准
- •Have any history of or active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease that is considered clinically significant, is not currently controlled by medication, and is stable as deemed by the Investigator
- •Are currently taking antibiotics for bacterial overgrowth
- •Have known or suspected pregnancy, planned pregnancy, or lactation
- •Have a planned surgery during the course of the study
- •Have a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
研究组 & 干预措施
All Subjects
Experimental
Assigned to receive open-label 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
干预措施: 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) (Drug)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Up to 120 Days
次要结局
未报告次要终点
研究者
研究点 (5)
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