A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

Phase 2

Completed

Conditions: Diabetic Gastroparesis
Idiopathic Gastroparesis

Interventions: Drug: NG101
Drug: Placebo

Registration Number: NCT04303195

Lead Sponsor: Neurogastrx, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 161

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NG101 - 5 mg	NG101	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101 - 10 mg	NG101	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101 - 20 mg	NG101	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Placebo	Placebo	Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Nausea Severity Score	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 Outcome Measures

Name	Time	Method
Change From Baseline in Early Satiety Severity Score	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) for early satiety severity score. 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.
Change From Baseline in Postprandial Fullness Severity Score	Baseline to Week 12	Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score. 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 negative change from baseline indicates improvement.
Change From Baseline in Abdominal Pain Severity Score	Baseline to Week 12	Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score. 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 negative change from baseline indicates improvement.
Change From Baseline in Discrete Episodes of Vomiting	Baseline to Week 12	Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for the number of discrete episodes of vomiting. Participants were asked to record the number of episodes of vomiting in the past 24 hours. Each episode counts as "1". A negative change from baseline indicates improvement.
Change From Baseline in 3-symptom Severity Score	Baseline to Week 12	Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 3-symptom severity score. 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, the 3-symptom severity score is the average of the mean daily scores of nausea, early satiety, and postprandial fullness severity scores. A negative change from baseline indicates improvement.
Change From Baseline in 4-symptom Severity Score	Baseline to Week 12	Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 4-symptom severity score. 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, the 4-symptom severity score is the average of the mean daily scores of nausea, early satiety, postprandial fullness, and abdominal pain severity scores. A negative change from baseline indicates improvement

Trial Locations

Locations (77): Digestive Health Specialists
🇺🇸
Dothan, Alabama, United States
G & L Research, LLC
🇺🇸
Foley, Alabama, United States
East View Medical Research
🇺🇸
Mobile, Alabama, United States
Phoenix Medical Group
🇺🇸
Peoria, Arizona, United States
Phoenix Clinical LLC
🇺🇸
Phoenix, Arizona, United States
Del Sol Research Management
🇺🇸
Tucson, Arizona, United States
Preferred Research Partners
🇺🇸
Little Rock, Arkansas, United States
GW Research, Inc
🇺🇸
Chula Vista, California, United States
Precision Research Institute, LLC
🇺🇸
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸
Corona, California, United States
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Digestive Health Specialists
🇺🇸Dothan, Alabama, United States