COMPLETED

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

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Conditions

Diabetic GastroparesisGastroparesisGastrointestinal diseaseDelayed gastric emptyingDigestive system diseasesNauseaVomitingStomachDopamine receptor antagonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-03-27
Study Completion:2025-12-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05832151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is a male or female ≥18 years of age;
  2. * Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;
  3. * Has a current diagnosis of diabetic gastroparesis defined by the following:
  4. 1. Persistent gastrointestinal symptoms that in the opinion of the Investigator are consistent with gastroparesis within 6 months prior to Screening; AND
  5. 2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.
  6. * Body mass index (BMI) between 18 and 49 kg/m2, inclusive;
  7. * Glycosylated hemoglobin (HbA1c) level \<10% at Screening;
  8. * If receiving treatment with GLP-1RA, may be considered for the study if all of the following criteria are satisfied:
  9. 1. The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management;
  10. 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;
  11. 3. Is tolerating the GLP-1RA well based on Investigator's judgment;
  12. 4. None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and
  13. 5. The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy.
  14. * Willing to washout from ongoing treatment for gastroparesis.
  1. * Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder);
  2. * Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition;
  3. * History or evidence of clinically significant arrhythmia;
  4. * History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;
  5. * Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;
  6. * Pyloric injection of botulinum toxin within 6 months of Screening;
  7. * Positive test for drugs of abuse;
  8. * Has a known allergy to eggs or spirulina;
  9. * Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Contacts and Locations

Study Locations (Sites)

Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305
United States
G & L Research, LLC
Foley, Alabama, 36535
United States
Clinical Research Associates, LLC
Huntsville, Alabama, 35801
United States
Phoenix Medical Research Institute, LLC
Peoria, Arizona, 85381
United States
Onyx Clinical Research
Phoenix, Arizona, 85381
United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715
United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, 72117
United States
Alliance Research Institute - Bell Gardens
Bell Gardens, California, 90201
United States
Hope Clinical Research LLC
Canoga Park, California, 91303
United States
Alliance Research Institute, LLC
Canoga Park, California, 91304
United States
Erick H. Alayo Medical Corporation
Chula Vista, California, 91910
United States
GW Research Inc.
Chula Vista, California, 91910
United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879
United States
New Hope Research Development
Corona, California, 92882
United States
Aurora Care Clinic
Costa Mesa, California, 92627
United States
Paragon Rx Clinical
Garden Grove, California, 92840
United States
Valley View Wellness and Medical Center - VVCRD
Garden Grove, California, 92845
United States
Torrance Clinical Research Institute Inc.
Lomita, California, 09717
United States
Angel City Research
Los Angeles, California, 90010
United States
Facey Medical Research
Mission Hills, California, 11333
United States
Millennium Clinical Trials
Thousand Oaks, California, 91360
United States
Innovative Research of West Florida
Clearwater, Florida, 33756
United States
USA and International Research Inc.
Doral, Florida, 33126
United States
Advanced Medical Research Group
Hollywood, Florida, 33021
United States
Nature Coast Clinical Research
Inverness, Florida, 34452
United States
ClinCloud LLC
Maitland, Florida, 32751
United States
A+ Research Inc
Miami, Florida, 33144
United States
International Research Associates LLC - Breton
Miami, Florida, 33183
United States
Advanced Research Institute Inc
New Port Richey, Florida, 34653
United States
Gastroenterology of Greater Orlando
Orange City, Florida, 32763
United States
Tandem Clinical Research - Viera
Viera, Florida, 32940
United States
Summit Clinical Research, LLC
Athens, Georgia, 30607
United States
Atlanta Center for Gastroenterology P.C.
Decatur, Georgia, 30033
United States
Medisphere Medical Research Center
Evansville, Indiana, 47714
United States
Lutheran Medical Group
Fort Wayne, Indiana, 46804
United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160
United States
DelRicht Clinical Research - Overland Park
Overland Park, Kansas, 66209
United States
Kansas Medical Clinic, P.A.
Topeka, Kansas, 66606
United States
Alliance for Multispecialty Research - Wichita West
Wichita, Kansas, 67205
United States
University of Louisville
Louisville, Kentucky, 40202
United States
DelRicht Clinical Research - Louisville
Louisville, Kentucky, 40205
United States
Delta Research Partners
Bastrop, Louisiana, 71201
United States
Tandem Clinical Research GI - Houma
Houma, Louisiana, 70363
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Tandem Clinical Research GI - Metairie
Metairie, Louisiana, 70006
United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
United States
Aa Mrc, Llc
Flint, Michigan, 48504
United States
Clinical Research Institute of Michigan, LLC - Troy
Troy, Michigan, 48098
United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519
United States
Kansas City Research Institute
Kansas City, Missouri, 64131
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
St. Charles Clinical Research
Weldon Spring, Missouri, 63304
United States
Montana Medical Research, Inc.
Missoula, Montana, 59808
United States
American Institute of Medical Research
Las Vegas, Nevada, 89123
United States
Digestive Disease Specialists
Las Vegas, Nevada, 89128
United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
Englewood, New Jersey, 07631
United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
Freehold, New Jersey, 07728
United States
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
Jackson, New Jersey, 08527
United States
NY Scientific
Brooklyn, New York, 11235
United States
Smart Medical Research
Brooklyn, New York, 11372
United States
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
United States
Tandem Clinical Research GI- New York
New York, New York, 10033
United States
A1 Clinical Network
Richmond Hill, New York, 11418
United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28144
United States
Atrium Health - Center for Digestive Health
Charlotte, North Carolina, 28204
United States
Research Carolina Elite, LLC
Denver, North Carolina, 28037
United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, 28304
United States
Cross Creek Medical, PA
Fayetteville, North Carolina, 28304
United States
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410
United States
Peters Medical Research
High Point, North Carolina, 27260
United States
Carolina's GI Research
Raleigh, North Carolina, 27612
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Remington Davis, Inc.
Columbus, Ohio, 43215
United States
DelRicht Clinical Research - Cincinnati
Mason, Ohio, 45040
United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145
United States
Options Health Research
Tulsa, Oklahoma, 74104
United States
Velocity Clinical Research
Medford, Oregon, 97504
United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
United States
Galen Medical Group - Downtown Gastroenterology Location
Chattanooga, Tennessee, 37343
United States
WR ClinSearch
Chattanooga, Tennessee, 37421
United States
DelRicht Clinical Research - Nashville
Henderson, Tennessee, 37075
United States
North Hills Medical Research Inc. (North Hills Familiy Medicine)
Arlington, Texas, 76012
United States
Zenos Clinical Research
Dallas, Texas, 75230
United States
Texas Gastro Research, LLC
El Paso, Texas, 10908
United States
Houston Methodist Research Institute
Houston, Texas, 77030
United States
Amir A Hassan, MD, PA
Houston, Texas, 77089
United States
Care and Cure Clinic
Houston, Texas, 77090
United States
Pioneer Research Solutions Inc.
Houston, Texas, 77099
United States
Epic Clinical Research
Lewisville, Texas, 75057
United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79905
United States
Biopharma Informatic, LLC
McAllen, Texas, 78503
United States
DelRicht Clinical Research - McKinney
McKinney, Texas, 75070
United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
United States
A1 Clinical Network
Spring, Texas, 77386
United States
HP Clinical Research (Val R. Hansen)
Bountiful, Utah, 84010
United States
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, 84065
United States
Manassas Clinical Research Center
Manassas, Virginia, 20110
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: CinDome Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-27
Study Completion Date2025-12-12

Study Record Updates

Study Start Date2023-03-27
Study Completion Date2025-12-12

Terms related to this study

Keywords Provided by Researchers

  • Gastroparesis
  • Diabetic gastroparesis
  • Gastrointestinal disease
  • Delayed gastric emptying
  • Digestive system diseases
  • Nausea
  • Vomiting
  • Stomach
  • Dopamine receptor antagonist

Additional Relevant MeSH Terms

  • Diabetic Gastroparesis