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.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Study Start: 2020-08-01
• Primary Completion: 2023-02-25
• Study Completion: 2023-02-25
• Status Verified: 2024-01
• Disposition First Submitted: 2024-01-25
• Last Update Submitted: 2024-01-27
• Disposition First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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
Incidence and severity of Adverse Events	Baseline to Week 12	Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
Change of Severity of Nausea	Baseline to Week 12	Change from Baseline at weeks 7 through12 as measured by patient's daily diary entries during participation in the study.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline of Symptoms	Baseline to Week 12	Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for early satiety severity score.
Change from Baseline	Baseline to Week 12	Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for 4-symptom severity score.

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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