A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
NCT ID: NCT05832151
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
382 participants
INTERVENTIONAL
2023-03-27
2025-12-12
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CIN-102: Dose 15mg or 10mg
CIN-102, Dose 15 mg or 10 mg, twice daily for 12 weeks
CIN-102 Dose 15mg or 10mg
2 capsules twice daily for 12 weeks
Placebo
Placebo for CIN-102, twice daily for 12 weeks
Placebo
2 capsules twice daily for 12 weeks
Interventions
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CIN-102 Dose 15mg or 10mg
2 capsules twice daily for 12 weeks
Placebo
2 capsules twice daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
2. 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:
1. The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
2. 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;
3. Is tolerating the GLP-1RA well based on Investigator's judgment;
4. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
5. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
* Willing to washout from ongoing treatment for gastroparesis.
Exclusion Criteria
* Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition;
* History or evidence of clinically significant arrhythmia;
* History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;
* Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;
* Pyloric injection of botulinum toxin within 6 months of Screening;
* Positive test for drugs of abuse;
* Has a known allergy to eggs or spirulina;
* Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
18 Years
ALL
No
Sponsors
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CinDome Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
G & L Research, LLC
Foley, Alabama, United States
Clinical Research Associates, LLC
Huntsville, Alabama, United States
Phoenix Medical Research Institute, LLC
Peoria, Arizona, United States
Onyx Clinical Research
Phoenix, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, United States
Alliance Research Institute - Bell Gardens
Bell Gardens, California, United States
Hope Clinical Research LLC
Canoga Park, California, United States
Alliance Research Institute, LLC
Canoga Park, California, United States
Erick H. Alayo Medical Corporation
Chula Vista, California, United States
GW Research Inc.
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
New Hope Research Development
Corona, California, United States
Aurora Care Clinic
Costa Mesa, California, United States
Paragon Rx Clinical
Garden Grove, California, United States
Valley View Wellness and Medical Center - VVCRD
Garden Grove, California, United States
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Angel City Research
Los Angeles, California, United States
Facey Medical Research
Mission Hills, California, United States
Millennium Clinical Trials
Thousand Oaks, California, United States
Innovative Research of West Florida
Clearwater, Florida, United States
USA and International Research Inc.
Doral, Florida, United States
Advanced Medical Research Group
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
ClinCloud LLC
Maitland, Florida, United States
A+ Research Inc
Miami, Florida, United States
International Research Associates LLC - Breton
Miami, Florida, United States
Advanced Research Institute Inc
New Port Richey, Florida, United States
Gastroenterology of Greater Orlando
Orange City, Florida, United States
Tandem Clinical Research - Viera
Viera, Florida, United States
Summit Clinical Research, LLC
Athens, Georgia, United States
Atlanta Center for Gastroenterology P.C.
Decatur, Georgia, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
DelRicht Clinical Research - Overland Park
Overland Park, Kansas, United States
Kansas Medical Clinic, P.A.
Topeka, Kansas, United States
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
DelRicht Clinical Research - Louisville
Louisville, Kentucky, United States
Delta Research Partners
Bastrop, Louisiana, United States
Tandem Clinical Research GI - Houma
Houma, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Tandem Clinical Research GI - Metairie
Metairie, Louisiana, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Aa Mrc, Llc
Flint, Michigan, United States
Clinical Research Institute of Michigan, LLC - Troy
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
St. Charles Clinical Research
Weldon Spring, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
American Institute of Medical Research
Las Vegas, Nevada, United States
Digestive Disease Specialists
Las Vegas, Nevada, United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
Englewood, New Jersey, United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
Freehold, New Jersey, United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson, New Jersey, United States
NY Scientific
Brooklyn, New York, United States
Smart Medical Research
Brooklyn, New York, United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, United States
Tandem Clinical Research GI- New York
New York, New York, United States
A1 Clinical Network
Richmond Hill, New York, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, United States
Atrium Health - Center for Digestive Health
Charlotte, North Carolina, United States
Research Carolina Elite, LLC
Denver, North Carolina, United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, United States
Cross Creek Medical, PA
Fayetteville, North Carolina, United States
Triad Clinical Trials LLC
Greensboro, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Carolina's GI Research
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Remington Davis, Inc.
Columbus, Ohio, United States
DelRicht Clinical Research - Cincinnati
Mason, Ohio, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, United States
Options Health Research
Tulsa, Oklahoma, United States
Velocity Clinical Research
Medford, Oregon, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga, Tennessee, United States
WR ClinSearch
Chattanooga, Tennessee, United States
DelRicht Clinical Research - Nashville
Henderson, Tennessee, United States
North Hills Medical Research Inc. (North Hills Familiy Medicine)
Arlington, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Texas Gastro Research, LLC
El Paso, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Amir A Hassan, MD, PA
Houston, Texas, United States
Care and Cure Clinic
Houston, Texas, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Biopharma Informatic, LLC
McAllen, Texas, United States
DelRicht Clinical Research - McKinney
McKinney, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
A1 Clinical Network
Spring, Texas, United States
HP Clinical Research (Val R. Hansen)
Bountiful, Utah, United States
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Study website
Other Identifiers
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CIN-102-123
Identifier Type: -
Identifier Source: org_study_id