A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis

Status: Completed
Location: See all (100) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo * To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo Participants will go through the following schedule: * Screening period (1-2 visits) * Lead-in period (1 visit) * Will complete a Gastric Emptying Breath Test (GEBT) * Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation * 12-week treatment period (7 visits) * Study drug taken twice daily by mouth * Will complete daily diaries and other PROs as described in protocol * 1 week follow-up (1 visit) Researchers will compare the effects of the following treatments: * Drug- CIN-102 Dose 15 mg or 10 mg * Drug- Placebo

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Is a male or female ≥18 years of age;

• Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;

• Has a current diagnosis of diabetic gastroparesis defined by the following:

‣ Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND

⁃ Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.

• Body mass index (BMI) between 18 and 49 kg/m2, inclusive;

• Glycosylated hemoglobin (HbA1c) level \<10% at Screening;

• If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:

‣ The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;

⁃ Has been on a stable dose of GLP-1RA for a minimum of 3 months before Screening and is anticipated to sustain the same dose during GEBT and throughout the study;

⁃ Is tolerating the GLP-1RA well based on Investigator's judgment;

⁃ None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and

⁃ The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.

• Willing to washout from ongoing treatment for gastroparesis.

Locations
United States
Alabama
Digestive Health Specialists of the Southeast
Dothan
G & L Research, LLC
Foley
Clinical Research Associates, LLC
Huntsville
Arkansas
Applied Research Center of Arkansas
Little Rock
Preferred Research Partners, Inc.
Little Rock
Arkansas Gastroenterology - North Little Rock
North Little Rock
Arizona
Phoenix Medical Research Institute, LLC
Peoria
Onyx Clinical Research
Phoenix
Del Sol Research Management, LLC
Tucson
California
Alliance Research Institute - Bell Gardens
Bell Gardens
Alliance Research Institute, LLC
Canoga Park
Hope Clinical Research LLC
Canoga Park
Erick H. Alayo Medical Corporation
Chula Vista
GW Research Inc.
Chula Vista
Kindred Medical Institute for Clinical Trials, LLC
Corona
New Hope Research Development
Corona
Aurora Care Clinic
Costa Mesa
Paragon Rx Clinical
Garden Grove
Valley View Wellness and Medical Center - VVCRD
Garden Grove
Torrance Clinical Research Institute Inc.
Lomita
Angel City Research
Los Angeles
Facey Medical Research
Mission Hills
Millennium Clinical Trials
Thousand Oaks
Florida
Innovative Research of West Florida
Clearwater
USA and International Research Inc.
Doral
Advanced Medical Research Group
Hollywood
Nature Coast Clinical Research
Inverness
ClinCloud LLC
Maitland
A+ Research Inc
Miami
International Research Associates LLC - Breton
Miami
Advanced Research Institute Inc
New Port Richey
Gastroenterology of Greater Orlando
Orange City
Tandem Clinical Research - Viera
Viera
Georgia
Summit Clinical Research, LLC
Athens
Atlanta Center for Gastroenterology P.C.
Decatur
Indiana
Medisphere Medical Research Center
Evansville
Lutheran Medical Group
Fort Wayne
Kansas
University of Kansas Medical Center (KUMC)
Kansas City
DelRicht Clinical Research - Overland Park
Overland Park
Kansas Medical Clinic, P.A.
Topeka
Alliance for Multispecialty Research - Wichita West
Wichita
Kentucky
DelRicht Clinical Research - Louisville
Louisville
University of Louisville
Louisville
Louisiana
Delta Research Partners
Bastrop
Tandem Clinical Research GI - Houma
Houma
Tandem Clinical Research
Marrero
Tandem Clinical Research GI - Metairie
Metairie
Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield
Aa Mrc, Llc
Flint
Clinical Research Institute of Michigan, LLC - Troy
Troy
Gastroenterology Associates of Western Michigan
Wyoming
Missouri
Kansas City Research Institute
Kansas City
Washington University School of Medicine
St Louis
St. Charles Clinical Research
Weldon Spring
Montana
Montana Medical Research, Inc.
Missoula
North Carolina
Atrium Health - Center for Digestive Health
Charlotte
OnSite Clinical Solutions, LLC
Charlotte
Research Carolina Elite, LLC
Denver
Coastal Research Institute, LLC
Fayetteville
Cross Creek Medical, PA
Fayetteville
Triad Clinical Trials LLC
Greensboro
Peters Medical Research
High Point
Carolina's GI Research
Raleigh
New Jersey
Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
Englewood
Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
Freehold
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson
Nevada
American Institute of Medical Research
Las Vegas
Digestive Disease Specialists
Las Vegas
New York
NY Scientific
Brooklyn
Smart Medical Research
Brooklyn
Velocity Clinical Research - Syracuse
East Syracuse
Tandem Clinical Research GI- New York
New York
A1 Clinical Network
Richmond Hill
Ohio
Cleveland Clinic
Cleveland
Remington Davis, Inc.
Columbus
DelRicht Clinical Research - Cincinnati
Mason
Northshore Gastroenterology Research, LLC
Westlake
Oklahoma
Options Health Research
Tulsa
Oregon
Velocity Clinical Research
Medford
Pennsylvania
Susquehanna Research Group, LLC
Harrisburg
Tennessee
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga
WR ClinSearch
Chattanooga
DelRicht Clinical Research - Nashville
Henderson
Texas
North Hills Medical Research Inc. (North Hills Familiy Medicine)
Arlington
Zenos Clinical Research
Dallas
Texas Gastro Research, LLC
El Paso
Amir A Hassan, MD, PA
Houston
Care and Cure Clinic
Houston
Houston Methodist Research Institute
Houston
Pioneer Research Solutions Inc.
Houston
Epic Clinical Research
Lewisville
Texas Tech University Health Sciences Center
Lubbock
Biopharma Informatic, LLC
Mcallen
DelRicht Clinical Research - McKinney
Mckinney
Gastroenterology Research of San Antonio
San Antonio
A1 Clinical Network
Spring
Utah
HP Clinical Research (Val R. Hansen)
Bountiful
Velocity Clinical Research - Salt Lake City
West Jordan
Virginia
Manassas Clinical Research Center
Manassas
Wisconsin
Wisconsin Center for Advanced Research
Milwaukee
Time Frame
Start Date: 2023-03-27
Completion Date: 2025-12-12
Participants
Target number of participants: 382
Treatments
Experimental: CIN-102: Dose 15mg or 10mg
CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks
Placebo_comparator: Placebo
Placebo for CIN-102, twice daily for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: CinDome Pharma, Inc.

This content was sourced from clinicaltrials.gov