Clinical trial NCT04303195: A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
Official title: A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Idiopathic Gastroparesis
Lead sponsor: Neurogastrx, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Severity of Nausea
timeFrame: Baseline to Week 12
measure: Incidence and severity of Adverse Events
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change from Baseline of Symptoms
timeFrame: Baseline to Week 12
measure: Change from Baseline of Symptoms
timeFrame: Baseline to Week 12
measure: Change from Baseline
timeFrame: Baseline to Week 12
measure: Change from Baseline
timeFrame: Baseline to Week 12
measure: Change from Baseline
timeFrame: Baseline to Week 12
measure: Change from Baseline
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Foley
country: United States
facility: G & L Research, LLC
state: Alabama
city: Mobile
country: United States
facility: East View Medical Research
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Group
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research, Inc
state: California
city: Chula Vista
country: United States
facility: Precision Research Institute, LLC
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc.
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical, Inc
state: California
city: Irvine
country: United States
facility: United Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Prime Care Clinical Rsearch
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute, Inc.
state: California
city: Los Angeles
country: United States
facility: Angel City Research
state: California
city: Murrieta
country: United States
facility: United Clinical Research
state: California
city: Northridge
country: United States
facility: Diabetes Medical Center of California
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Innovation Medical Group, LLC.
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland-Grover Clinical Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Miami
country: United States
facility: Verus Clinical Research, Corp
state: Florida
city: Miami
country: United States
facility: APF Research, LLC
state: Florida
city: Miami
country: United States
facility: Panax Clinical Research
state: Florida
city: Miami
country: United States
facility: International Research Associates LLC
state: Florida
city: Miami
country: United States
facility: PharmaSouth Research
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pinellas Park
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Decatur
country: United States
facility: IResearch Atlanta LLC
state: Georgia
city: Chicago
country: United States
facility: Claude Mandel Medical Center
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center LLC
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Shawnee Mission
country: United States
facility: West Glen GI
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Aa Mrc Llc
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Missoula
country: United States
facility: KLEO Health & Research
state: Montana
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Las Vegas
country: United States
facility: Digestive Disease Specialists
state: Nevada
city: Albuquerque
country: United States
facility: Lovelace Respiratory Rsearch Institute
state: New Mexico
city: New York
country: United States
facility: Synexus Clinical Research
state: New York
city: New York
country: United States
facility: Tandem Clinical Research GI, LLC
state: New York
city: Charlotte
country: United States
facility: Javara Research
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Edmond
country: United States
facility: Draelos Metabolic Center
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Jackson
country: United States
facility: Transsouth Healthcare PC
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Austin
country: United States
facility: Avant Research Associates
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Kerville
country: United States
facility: Sante Clinical Research
state: Texas
city: McAllen
country: United States
facility: Rio Grande Gastroenterology
state: Texas
city: Pearland
country: United States
facility: DM Clinical Research Solutions PC
state: Texas
city: Plano
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Plano
state: Texas
city: San Antonio
country: United States
facility: Sun Research
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research
state: Texas
city: Tomball
country: United States
facility: Horizon Clinical Research- Tomball
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Spokane
country: United States
facility: Velocity Clinical Research Spokane
state: Washington
Study officials:
References: