A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
- Conditions
- Diabetic GastroparesisIdiopathic Gastroparesis
- Interventions
- 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
- 162
- 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
- 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 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.
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).
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (77)
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
International Research Associates LLC
🇺🇸Miami, Florida, United States
Panax Clinical Research
🇺🇸Miami, Florida, United States
PharmaSouth Research
🇺🇸Miami, Florida, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
G & L Research, LLC
🇺🇸Foley, Alabama, United States
Torrance Clinical Research Institute, Inc.
🇺🇸Lomita, California, United States
Digestive Health Specialists
🇺🇸Dothan, Alabama, United States
Prime Care Clinical Rsearch
🇺🇸Laguna Hills, California, United States
GW Research, Inc
🇺🇸Chula Vista, California, United States
Paragon Rx Clinical, Inc
🇺🇸Garden Grove, California, United States
Diagnamics Inc.
🇺🇸Encinitas, California, United States
Angel City Research
🇺🇸Los Angeles, California, United States
Precision Research Institute, LLC
🇺🇸Chula Vista, California, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
🇺🇸Pinellas Park, Florida, United States
East View Medical Research
🇺🇸Mobile, Alabama, United States
Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
Medisphere Medical Research Center LLC
🇺🇸Evansville, Indiana, United States
Agile Clinical Research Trials, LLC
🇺🇸Atlanta, Georgia, United States
Clinical Trials of America
🇺🇸West Monroe, Louisiana, United States
Sensible Healthcare
🇺🇸Ocoee, Florida, United States
IResearch Atlanta LLC
🇺🇸Decatur, Georgia, United States
Tandem Clinical Research GI, LLC
🇺🇸New York, New York, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Dayton Gastroenterology Inc.
🇺🇸Beavercreek, Ohio, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Sun Research
🇺🇸San Antonio, Texas, United States
West Glen GI
🇺🇸Shawnee Mission, Kansas, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
Phoenix Medical Group
🇺🇸Peoria, Arizona, United States
Innovative Research of West Florida
🇺🇸Clearwater, Florida, United States
West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
APF Research, LLC
🇺🇸Miami, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
Del Sol Research Management
🇺🇸Tucson, Arizona, United States
Verus Clinical Research, Corp
🇺🇸Miami, Florida, United States
ENCORE Borland-Grover Clinical Research
🇺🇸Jacksonville, Florida, United States
Innovation Medical Group, LLC.
🇺🇸Fort Lauderdale, Florida, United States
KLEO Health & Research
🇺🇸Missoula, Montana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
Aa Mrc Llc
🇺🇸Flint, Michigan, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Digestive Disease Specialists
🇺🇸Las Vegas, Nevada, United States
Transsouth Healthcare PC
🇺🇸Jackson, Tennessee, United States
Phoenix Clinical LLC
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Avita Clinical Research
🇺🇸Tampa, Florida, United States
Synexus Clinical Research
🇺🇸San Antonio, Texas, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
Draelos Metabolic Center
🇺🇸Edmond, Oklahoma, United States
Options Health Research
🇺🇸Tulsa, Oklahoma, 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
Southern Star Research Institute
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research Spokane
🇺🇸Spokane, Washington, United States
Horizon Clinical Research- Tomball
🇺🇸Tomball, Texas, United States
Diabetes Medical Center of California
🇺🇸Northridge, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
United Clinical Research
🇺🇸Murrieta, California, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Claude Mandel Medical Center
🇺🇸Chicago, Illinois, United States
Lovelace Respiratory Rsearch Institute
🇺🇸Albuquerque, New Mexico, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
AES - DRS - Synexus Clinical Research US, Inc. - Plano
🇺🇸Plano, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Avant Research Associates
🇺🇸Austin, Texas, United States
Javara Research
🇺🇸Charlotte, North Carolina, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States