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

Diabetic Gastroparesis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303195
• Other study ID #: NG101-201
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: February 25, 2023

Study information

• Verified date: January 2024
• Source: Neurogastrx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 25, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis
• Idiopathic Gastroparesis

Intervention

Drug:
• NG101
Capsules
• Placebo
Capsules

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Neurogastrx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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