A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 77
- 主要终点
- Change From Baseline of Nausea Severity Score
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.
详细描述
This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with placebo in participants with diabetic or idiopathic gastroparesis.
The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult patients with diabetic or idiopathic gastroparesis
- •Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)
- •Documented evidence of no mechanical obstruction
- •Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test
排除标准
- •Uncontrolled diabetes (defined as HgbA1c > 10%)
- •Severe postural symptoms or evidence of unexplained recurrent dizziness
- •Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms
- •Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
- •Participant engages in daily recreational use of marijuana
- •Prolactin levels > 2 x ULN
研究组 & 干预措施
Placebo
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
干预措施: Placebo (Drug)
NG101 - 5 mg
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
干预措施: NG101 (Drug)
NG101 - 10 mg
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
干预措施: NG101 (Drug)
NG101 - 20 mg
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
干预措施: NG101 (Drug)
结局指标
主要结局
Change From Baseline of Nausea Severity Score
时间窗: Baseline to Week 12
Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.
次要结局
- Change From Baseline in Early Satiety Severity Score(Baseline to Week 12)
- Change From Baseline in Postprandial Fullness Severity Score(Baseline to Week 12)
- Change From Baseline in Abdominal Pain Severity Score(Baseline to Week 12)
- Change From Baseline in Discrete Episodes of Vomiting(Baseline to Week 12)
- Change From Baseline in 3-symptom Severity Score(Baseline to Week 12)
- Change From Baseline in 4-symptom Severity Score(Baseline to Week 12)