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

Primary Purpose

Diabetic Gastroparesis, Idiopathic Gastroparesis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NG101
Placebo
Sponsored by
Neurogastrx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetic Gastroparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Digestive Health Specialists
  • G & L Research, LLC
  • East View Medical Research
  • Phoenix Medical Group
  • Phoenix Clinical LLC
  • Del Sol Research Management
  • Preferred Research Partners
  • GW Research, Inc
  • Precision Research Institute, LLC
  • Kindred Medical Institute for Clinical Trials, LLC
  • Diagnamics Inc.
  • Paragon Rx Clinical, Inc
  • United Clinical Research
  • Prime Care Clinical Rsearch
  • Torrance Clinical Research Institute, Inc.
  • Angel City Research
  • United Clinical Research
  • Diabetes Medical Center of California
  • Precision Research Institute
  • Peak Gastroenterology Associates
  • Innovative Research of West Florida
  • Innovation Medical Group, LLC.
  • ENCORE Borland-Grover Clinical Research
  • ClinCloud, LLC
  • Verus Clinical Research, Corp
  • APF Research, LLC
  • Panax Clinical Research
  • International Research Associates LLC
  • PharmaSouth Research
  • Sensible Healthcare
  • Innovation Medical Research Center
  • AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
  • Avita Clinical Research
  • Agile Clinical Research Trials, LLC
  • IResearch Atlanta LLC
  • Claude Mandel Medical Center
  • Medisphere Medical Research Center LLC
  • Indiana University Hospital
  • Integrated Clinical Trial Services, Inc.
  • West Glen GI
  • Kansas Medical Clinic
  • University of Louisville
  • Tandem Clinical Research GI, LLC
  • Clinical Trials of America
  • Johns Hopkins Bayview Medical Center
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • Aa Mrc Llc
  • West Michigan Clinical Research Center
  • KLEO Health & Research
  • Clinical Research of South Nevada
  • Advanced Biomedical Research of America
  • Digestive Disease Specialists
  • Lovelace Respiratory Rsearch Institute
  • Synexus Clinical Research
  • Tandem Clinical Research GI, LLC
  • Javara Research
  • Cumberland Research Associates
  • Triad Clinical Trials
  • Carolina Digestive Diseases
  • Dayton Gastroenterology Inc.
  • Hometown Urgent Care and Research
  • Hometown Urgent Care and Research
  • Hometown Urgent Care and Research
  • Draelos Metabolic Center
  • Options Health Research
  • Transsouth Healthcare PC
  • Quality Medical Research
  • Avant Research Associates
  • Texas Tech University Health Sciences Center
  • Biopharma Informatic, LLC
  • Biopharma Informatic, LLC
  • Sante Clinical Research
  • Rio Grande Gastroenterology
  • DM Clinical Research Solutions PC
  • AES - DRS - Synexus Clinical Research US, Inc. - Plano
  • Sun Research
  • Southern Star Research Institute
  • Synexus Clinical Research
  • Horizon Clinical Research- Tomball
  • Manassas Clinical Research Center
  • Digestive and Liver Disease Specialists
  • Velocity Clinical Research Spokane

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

NG101 - 5 mg

NG101 - 10 mg

NG101 - 20 mg

Placebo

Arm Description

NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks

Outcomes

Primary Outcome Measures

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.
Incidence and severity of Adverse Events
Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 12, 2020
Last Updated
March 27, 2023
Sponsor
Neurogastrx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04303195
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 25, 2023 (Actual)
Study Completion Date
February 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogastrx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis, Idiopathic Gastroparesis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NG101 - 5 mg
Arm Type
Experimental
Arm Description
NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Arm Title
NG101 - 10 mg
Arm Type
Experimental
Arm Description
NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Arm Title
NG101 - 20 mg
Arm Type
Experimental
Arm Description
NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
NG101
Other Intervention Name(s)
metopimazine mesylate
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
Change of Severity of Nausea
Description
Change from Baseline at weeks 7 through12 as measured by patient's daily diary entries during participation in the study.
Time Frame
Baseline to Week 12
Title
Incidence and severity of Adverse Events
Description
Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline of Symptoms
Description
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.
Time Frame
Baseline to Week 12
Title
Change from Baseline of Symptoms
Description
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.
Time Frame
Baseline to Week 12
Title
Change from Baseline
Description
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.
Time Frame
Baseline to Week 12
Title
Change from Baseline
Description
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.
Time Frame
Baseline to Week 12
Title
Change from Baseline
Description
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.
Time Frame
Baseline to Week 12
Title
Change from Baseline
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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