NCT02289846已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
研究概览
简要总结
The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit.
- •Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus.
- •Patient has a diagnosis of DGP with no history or evidence of mechanical obstruction, symptoms for at least 3 consecutive months preceding the Screening Visit, and delayed gastric emptying of solids documented within 2 years of the Screening Visit.
- •Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient's gastroduodenal symptoms.
- •Patient is compliant with eDiary completion.
- •Patient agrees to refrain from making any new, major lifestyle changes.
- •Patient is fluent and literate in English.
排除标准
- •Patient has a history or current symptoms of any organic or structural disease that, in the opinion of the investigator, can cause abdominal pain or discomfort and may confound the assessment of DGP symptoms.
- •Patients with rumination syndrome, cyclic vomiting syndrome, anorexia nervosa, or bulimia.
- •Patient is currently using a gastric electric stimulator or has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
- •Patient has been hospitalized within the 2 months prior to the Screening Visit for uncontrolled diabetes mellitus, DGP, or associated malnutrition.
- •Patient reports significant diarrhea during the four weeks prior to the Screening Visit, or more than 2 days during either week of the Pretreatment Period.
- •Patient has had surgery of the GI tract any time before the Screening Visit, an appendectomy or cholecystectomy during the 3 months before the Screening Visit, non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months, or other major non-GI surgery during the 30 days before the Screening Visit.
- •Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable).
研究组 & 干预措施
Placebo QD AM + IW-9179 QD PM
Experimental
Placebo once in the morning and IW-9179 once in the evening.
干预措施: Matching Placebo (Drug)
Placebo QD AM + IW-9179 QD PM
Experimental
Placebo once in the morning and IW-9179 once in the evening.
干预措施: IW-9179 (Drug)
Placebo BID
Placebo Comparator
Placebo once in the morning and once in the evening.
干预措施: Matching Placebo (Drug)
IW-9179 QD AM + Placebo QD PM
Experimental
IW-9179 once in the morning and placebo once in the evening.
干预措施: IW-9179 (Drug)
IW-9179 QD AM + Placebo QD PM
Experimental
IW-9179 once in the morning and placebo once in the evening.
干预措施: Matching Placebo (Drug)
IW-9179 BID
Experimental
IW-9179 once in the morning and once in the evening
干预措施: IW-9179 (Drug)
结局指标
主要结局
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
时间窗: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
次要结局
未报告次要终点
研究者
研究点 (1)
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