Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Evoke Pharma
- 入组人数
- 205
- 试验地点
- 49
- 主要终点
- Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
研究概览
简要总结
The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.
详细描述
Diabetic women with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non pregnant, non lactating female subjects between the ages of 18 and 75 years
- •Willingness and ability to give written informed consent
- •The ability to read, understand and speak English
- •Prior diagnosis of Type 1 or Type 2 diabetes
- •Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
- •A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
- •Subjects of childbearing potential must agree to use contraception
- •Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study
排除标准
- •Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
- •A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
- •A history of, or physical findings suggestive of, tardive dyskinesia
- •A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
- •A history of allergy to any of the ingredients in the study drug formulation
- •A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS)
- •Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
- •Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening
- •Hemoglobin A1c >11.5% at screening
- •Subjects who are trying to conceive, are pregnant, or are lactating
研究组 & 干预措施
10 mg Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
干预措施: Metoclopramide Nasal Spray (Drug)
Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
干预措施: Placebo Nasal Spray (Drug)
结局指标
主要结局
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
时间窗: Baseline Period to Week 4 of the Treatment Period
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
次要结局
未报告次要终点