A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
NCT ID: NCT04303195
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2020-08-01
2023-02-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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NG101 - 5 mg
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101
Capsules
NG101 - 10 mg
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101
Capsules
NG101 - 20 mg
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101
Capsules
Placebo
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Placebo
Capsules
Interventions
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NG101
Capsules
Placebo
Capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Neurogastrx, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Diagnamics Inc.
Encinitas, California, United States
Paragon Rx Clinical, Inc
Garden Grove, California, United States
United Clinical Research
Irvine, California, United States
Prime Care Clinical Rsearch
Laguna Hills, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Angel City Research
Los Angeles, California, United States
United Clinical Research
Murrieta, California, United States
Diabetes Medical Center of California
Northridge, California, United States
Precision Research Institute
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Innovative Research of West Florida
Clearwater, Florida, United States
Innovation Medical Group, LLC.
Fort Lauderdale, Florida, United States
ENCORE Borland-Grover Clinical Research
Jacksonville, Florida, United States
ClinCloud, LLC
Maitland, Florida, United States
Verus Clinical Research, Corp
Miami, Florida, United States
APF Research, LLC
Miami, Florida, United States
Panax Clinical Research
Miami, Florida, United States
International Research Associates LLC
Miami, Florida, United States
PharmaSouth Research
Miami, Florida, United States
Sensible Healthcare
Ocoee, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park, Florida, United States
Avita Clinical Research
Tampa, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
IResearch Atlanta LLC
Decatur, Georgia, United States
Claude Mandel Medical Center
Chicago, Illinois, United States
Medisphere Medical Research Center LLC
Evansville, Indiana, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
West Glen GI
Shawnee Mission, Kansas, United States
Kansas Medical Clinic
Topeka, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States
Clinical Trials of America
West Monroe, Louisiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Aa Mrc Llc
Flint, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
KLEO Health & Research
Missoula, Montana, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Digestive Disease Specialists
Las Vegas, Nevada, United States
Lovelace Respiratory Rsearch Institute
Albuquerque, New Mexico, United States
Synexus Clinical Research
New York, New York, United States
Tandem Clinical Research GI, LLC
New York, New York, United States
Javara Research
Charlotte, North Carolina, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
Carolina Digestive Diseases
Greenville, North Carolina, United States
Dayton Gastroenterology Inc.
Beavercreek, Ohio, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Draelos Metabolic Center
Edmond, Oklahoma, United States
Options Health Research
Tulsa, Oklahoma, United States
Transsouth Healthcare PC
Jackson, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Avant Research Associates
Austin, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Sante Clinical Research
Kerville, Texas, United States
Rio Grande Gastroenterology
McAllen, Texas, United States
DM Clinical Research Solutions PC
Pearland, Texas, United States
AES - DRS - Synexus Clinical Research US, Inc. - Plano
Plano, Texas, United States
Sun Research
San Antonio, Texas, United States
Southern Star Research Institute
San Antonio, Texas, United States
Synexus Clinical Research
San Antonio, Texas, United States
Horizon Clinical Research- Tomball
Tomball, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Velocity Clinical Research Spokane
Spokane, Washington, United States
Countries
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References
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Loesch J, Hamza E, Pasricha PJ, Nee J, Cline M, MacDougall J, Simons M, Brown JT, Garg S, Hoscheit M, Gabbard S, De Colle C, Lembo A. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Metopimazine Mesylate (NG101) in Participants With Gastroparesis. Am J Gastroenterol. 2025 May 14. doi: 10.14309/ajg.0000000000003534. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NG101-201
Identifier Type: -
Identifier Source: org_study_id
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