A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Diabetic Gastroparesis
- Sponsor
- Neurogastrx, Inc.
- Enrollment
- 161
- Locations
- 77
- Primary Endpoint
- Change From Baseline of Nausea Severity Score
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Intervention: Placebo
NG101 - 5 mg
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Intervention: NG101
NG101 - 10 mg
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Intervention: NG101
NG101 - 20 mg
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Intervention: NG101
Outcomes
Primary Outcomes
Change From Baseline of Nausea Severity Score
Time Frame: 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.
Secondary Outcomes
- 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)