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

A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Gastroparesis; Idiopathic Gastroparesis
• Intervention / Treatment: Drug: Placebo; Drug: NG101

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 Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists
    • Foley, Alabama, United States, 36535
      • G & L Research, LLC
    • Mobile, Alabama, United States, 36606
      • East View Medical Research
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Group
    • Phoenix, Arizona, United States, 85014-2151
      • Phoenix Clinical LLC
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Chula Vista, California, United States, 91910
      • Precision Research Institute, LLC
    • Chula Vista, California, United States, 91910
      • GW Research, Inc
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Encinitas, California, United States, 92024
      • Diagnamics Inc.
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical, Inc
    • Irvine, California, United States, 92618
      • United Clinical Research
    • Laguna Hills, California, United States, 92653
      • Prime Care Clinical Rsearch
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute, Inc.
    • Los Angeles, California, United States, 90010
      • Angel City Research
    • Murrieta, California, United States, 92563
      • United Clinical Research
    • Northridge, California, United States, 91325
      • Diabetes Medical Center of California
    • San Diego, California, United States, 92114
      • Precision Research Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Peak Gastroenterology Associates
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Innovation Medical Group, LLC.
    • Jacksonville, Florida, United States, 32256
      • ENCORE Borland-Grover Clinical Research
    • Maitland, Florida, United States, 32751
      • ClinCloud, LLC
    • Miami, Florida, United States, 33156
      • International Research Associates LLC
    • Miami, Florida, United States, 33125
      • Verus Clinical Research, Corp
    • Miami, Florida, United States, 33134
      • APF Research, LLC
    • Miami, Florida, United States, 33155-1691
      • Panax Clinical Research
    • Miami, Florida, United States, 33175
      • PharmaSouth Research
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Pinellas Park, Florida, United States, 33781
      • AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
    • Tampa, Florida, United States, 33613
      • Avita Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • AGILE Clinical Research Trials, LLC
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta LLC
  • Illinois
    • Chicago, Illinois, United States, 60617
      • Claude Mandel Medical Center
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center LLC
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc.
  • Kansas
    • Shawnee Mission, Kansas, United States, 66217
      • West Glen GI
    • Topeka, Kansas, United States, 66606
      • Kansas Medical Clinic
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research GI, LLC
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials Of America
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Flint, Michigan, United States, 48504
      • Aa Mrc Llc
    • Wyoming, Michigan, United States, 49519
      • West Michigan Clinical Research Center
  • Montana
    • Missoula, Montana, United States, 59803
      • KLEO Health & Research
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
    • Las Vegas, Nevada, United States, 89123
      • Advanced Biomedical Research of America
    • Las Vegas, Nevada, United States, 89128
      • Digestive Disease Specialists
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Respiratory Rsearch Institute
  • New York
    • New York, New York, United States, 10017
      • Synexus Clinical Research
    • New York, New York, United States, 10033
      • Tandem Clinical Research GI, LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Javara Research
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates
    • Greensboro, North Carolina, United States, 27410
      • Triad Clinical Trials
    • Greenville, North Carolina, United States, 27834
      • Carolina Digestive Diseases
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Dayton Gastroenterology Inc.
    • Cincinnati, Ohio, United States, 45215
      • Hometown Urgent Care and Research
    • Columbus, Ohio, United States, 43214
      • Hometown Urgent Care and Research
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Draelos Metabolic Center
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Transsouth Healthcare PC
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research
  • Texas
    • Austin, Texas, United States, 78704
      • Avant Research Associates
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, Llc
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, Llc
    • Kerville, Texas, United States, 78028
      • Sante Clinical Research
    • McAllen, Texas, United States, 78503
      • Rio Grande Gastroenterology
    • Pearland, Texas, United States, 77584
      • DM Clinical Research Solutions PC
    • Plano, Texas, United States, 75093-8157
      • AES - DRS - Synexus Clinical Research US, Inc. - Plano
    • San Antonio, Texas, United States, 78229
      • Synexus Clinical Research
    • San Antonio, Texas, United States, 78215
      • Sun Research
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute
    • Tomball, Texas, United States, 77375
      • Horizon Clinical Research- Tomball
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Washington
    • Spokane, Washington, United States, 99202
      • Velocity Clinical Research Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NG101 - 5 mg; NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: NG101; Capsules; Other Names: metopimazine mesylate
Experimental: NG101 - 10 mg; NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: NG101; Capsules; Other Names: metopimazine mesylate
Experimental: NG101 - 20 mg; NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: NG101; Capsules; Other Names: metopimazine mesylate
Placebo Comparator: Placebo; Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: Placebo; Capsules

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of Symptoms	Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for number of discrete episodes of vomiting.	Baseline to Week 12
Change from Baseline of Symptoms	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.	Baseline to Week 12
Change from Baseline	Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.	Baseline to Week 12
Change from Baseline	Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for abdominal pain severity score.	Baseline to Week 12
Change from Baseline	Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for 3-symptom severity score.	Baseline to Week 12
Change from Baseline	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.	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Neurogastrx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): February 25, 2023
• Study Completion (Actual): February 25, 2023

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Metopimazine
• Other Study ID Numbers: NG101-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No