ACTIVE_NOT_RECRUITING

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

Talk to us

Conditions

Idiopathic GastroparesisGastroparesisVomitingEarly satietyBloatingEpigastric painAbdominal painDelayed gastric emptyingDopamine receptor antagonistNauseaPost-prandial fullnessStomach painGastric statisDysmotilityGastric motility

Quick Navigation

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 to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo * To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo Participants will go through the following schedule: * Pre-screening (1 visit) * Screening \& Lead-In (1-2 visits) * 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. * Lead-In Period (1 visit) * 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: * 15 mg CIN-102, taken orally BID for 12 weeks * 10 mg CIN-102, taken orally BID for 12 weeks * Placebo for CIN-102, taken orally BID for 12 weeks

Official Title

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

Quick Facts

Study Start:2025-01-29
Study Completion:2026-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06899217

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 current diagnosis of gastroparesis defined by the following:
  3. 1. Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
  4. 2. Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT) at Visit 2.
  5. * Body mass index between 17 and 49 kg/m2, inclusive;
  6. * If receiving treatment with a Food and Drug Administration (FDA)-approved and marketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss or reduce risk of major adverse cardiovascular events, and/or, receiving any other agent(s) taken for weight loss, subjects may be considered for the study if ALL of the following criteria are satisfied:
  7. 1. Is not taking the agent(s) for the management of diabetes or blood glucose;
  8. 2. Has been on a stable dose of the agent(s) for at least 3 months before Screening and is expected to maintain the same dose throughout the study, including during GEBT;
  9. 3. Is tolerating the agent(s) well, according to the Investigator's judgment;
  10. 4. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
  11. 5. Symptoms of gastroparesis were present before starting the agent(s).
  1. * Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing, or active viral illness; cancer, medications, musculoskeletal or connective tissue disorders \[eg, scleroderma, systemic lupus erythematosus\], or other neurologic disorder \[eg, Parkinson's disease\], postural orthostatic tachycardia syndrome (POTS), etc.\]);
  2. * Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary;
  3. * Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening;
  4. * Has a known or suspected GI mechanical obstruction (eg, peptic stricture) as documented by upper GI endoscopy, upper GI radiographic series, plain film abdomen X-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
  5. * Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study;
  6. * Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure;
  7. * Has a history of gastric surgery;
  8. * Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease;
  9. * Has a history of severe and refractory constipation;
  10. * Has a history or evidence of clinically significant arrhythmia;
  11. * Currently receiving parenteral feeding or presence of a nasogastric or other gastric enteral tube (e.g. percutaneous endoscopic gastrostomy \[PEG\] or percutaneous endoscopic jejunostomy \[PEJ\] tube) for feeding or decompression; Note: patients receiving enteral feeding via a jejunostomy tube may be included if, in the opinion of the Investigator, the patient is also taking substantial oral solid intake and are not primarily dependent on enteral nutrition
  12. * Has a substance use disorder or a positive alcohol or positive drug screen.

Contacts and Locations

Study Locations (Sites)

Gastro Health - Birmingham
Birmingham, Alabama, 35235
United States
G & L Research, LLC
Foley, Alabama, 36535
United States
The Center for Clinical Trials
Saraland, Alabama, 36571
United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715
United States
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas, 72205
United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
United States
Hope Clinical Research LLC
Canoga Park, California, 91303
United States
Erick H. Alayo Medical Corporation
Chula Vista, California, 91910
United States
Flourish Research - Los Angeles (Covina)
Covina, California, 91723
United States
Gastro Care Institute
Lancaster, California, 93534
United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, 90017
United States
Acclaim Clinical Research
San Diego, California, 92120
United States
Focus Clinical Research - West Hills
West Hills, California, 91307
United States
University of Colorado Anschutz
Aurora, Colorado, 80045
United States
Rocky Mountain Gastroenterology (RMG)
Lakewood, Colorado, 80228
United States
Paradigm Research - Wheatridge
Wheat Ridge, Colorado, 80033
United States
Connecticut Clinical Research Institute, LLC
Bristol, Connecticut, 06010
United States
American Family Research Group
Cape Coral, Florida, 33909
United States
USA and International Research Inc.
Doral, Florida, 33126
United States
Unique Clinical Trials
Doral, Florida, 33172
United States
Advanced Medical Research Group
Hollywood, Florida, 33021
United States
Nature Coast Clinical Research
Inverness, Florida, 34452
United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
United States
Allied Biomedical Research Institute, Inc.
Miami, Florida, 33155
United States
Advanced Research Institute Inc
New Port Richey, Florida, 34653
United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761
United States
GCP Research
St. Petersburg, Florida, 33705
United States
Summit Clinical Research, LLC
Athens, Georgia, 30607
United States
DelRicht Clinical Research - Atlanta
Atlanta, Georgia, 30329
United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
GI Alliance - Gurnee
Gurnee, Illinois, 60031
United States
Carle Clinic - Urbana Main
Urbana, Illinois, 61801
United States
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa, 50265
United States
Kansas Medical Clinic, P.A.
Topeka, Kansas, 66606
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Delta Research Partners of West Monroe, LLC
Monroe, Louisiana, 71201
United States
NOLA Research Works
New Orleans, Louisiana, 70125
United States
Portland Gastroenterology Associates
Portland, Maine, 04101
United States
Capital Digestive Care - Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
United States
Sanmora Bespoke: Parkway Medical Association
Glen Burnie, Maryland, 21061
United States
Gastro Health - Framingham
Framingham, Massachusetts, 01702
United States
Aa Mrc, Llc
Flint, Michigan, 48504
United States
Huron Gastroenterology
Ypsilanti, Michigan, 48197
United States
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood, Mississippi, 39232
United States
KAD Clinical Research, LLC
St Louis, Missouri, 63123
United States
St. Charles Clinical Research
Weldon Spring, Missouri, 63304
United States
Quality Clinical Research, Inc
Omaha, Nebraska, 68114
United States
Excel Clinical Research
Las Vegas, Nevada, 89109
United States
Digestive Disease Specialists
Las Vegas, Nevada, 89128
United States
Advanced Research Institute - Reno
Reno, Nevada, 89511
United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109
United States
NY Scientific
Brooklyn, New York, 11235
United States
Westchester Putnam Gastro
Carmel, New York, 10512
United States
Atrium Health - Center for Gastroenterology and Hepatology MMP
Charlotte, North Carolina, 28204
United States
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina, 28304
United States
Carolina Digestive Diseases & Endoscopy Center
Greenville, North Carolina, 27834
United States
Peters Medical Research
High Point, North Carolina, 27260
United States
Hometown Urgent Care and Research (Cincinnati)
Cincinnati, Ohio, 45150
United States
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus
Columbus, Ohio, 43228
United States
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio, 45424
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, 44145
United States
Options Health Research
Tulsa, Oklahoma, 74104
United States
Advanced Research Institute - Portland
Portland, Oregon, 97223
United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, 17110
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Frontier Clinical Research, LLC - Smithfield
Smithfield, Pennsylvania, 15478
United States
PPCP Division of Gastroenterology
Summerville, South Carolina, 29486
United States
Galen Medical Group
Hixson, Tennessee, 37343
United States
Digestive Health - UT Health Austin
Austin, Texas, 78712
United States
Zenos Clinical Research
Dallas, Texas, 75230
United States
EPIC Medical Research
DeSoto, Texas, 75115
United States
Amir A Hassan, MD, PA
Houston, Texas, 77089
United States
Pioneer Research Solutions Inc.
Houston, Texas, 77099
United States
Epic Clinical Research
Lewisville, Texas, 75057
United States
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas, 76180
United States
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio, Texas, 78249
United States
GI Alliance - Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666
United States
Texas Digestive Specialists
Texas City, Texas, 78550
United States
Advanced Research Institute - Ogden
Ogden, Utah, 84405
United States
Advanced Research Institute - Sandy
Sandy City, Utah, 84092
United States
Manassas Clinical Research Center
Manassas, Virginia, 20110
United States
Capital Digestive Center
Norfolk, Virginia, 23502
United States
Advocate Aurora Health Research Institute
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 Date2025-01-29
Study Completion Date2026-06-23

Study Record Updates

Study Start Date2025-01-29
Study Completion Date2026-06-23

Terms related to this study

Keywords Provided by Researchers

  • Gastroparesis
  • Idiopathic Gastroparesis
  • Vomiting
  • Early satiety
  • Bloating
  • Epigastric pain
  • Abdominal pain
  • Delayed gastric emptying
  • Dopamine receptor antagonist
  • Nausea
  • Post-prandial fullness
  • Stomach pain
  • Gastric statis
  • Dysmotility
  • Gastric motility

Additional Relevant MeSH Terms

  • Idiopathic Gastroparesis