A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
Key facts
- Where
- Albuquerque, Athens, Atlanta, Aurora, Austin, Birmingham, Boise, Bristol, Brooklyn, Canoga Park, Cape Coral, Carmel, Charlotte, Chevy Chase, Chula Vista, Cincinnati, Columbus, Covina, Dallas, DeSoto, Doral, Fayetteville, Flint, Flowood, Foley, Framingham, Glen Burnie, Greenville, Gurnee, Harrisburg, High Point, Hixson, Hollywood, Houston, Huber Heights, Inverness, Jacksonville, Lakewood, Lancaster, Las Vegas, Lewisville, Little Rock, Los Angeles, Louisville, Manassas, Marietta, Marrero, Miami, Milwaukee, Monroe, New Orleans, New Port Richey, Norfolk, North Richland Hills, Ocoee, Ogden, Omaha, Philadelphia, Portland, Reno, San Antonio, San Diego, San Marcos, Sandy City, Saraland, Smithfield, St Louis, St. Petersburg, Summerville, Texas City, Topeka, Tucson, Tulsa, Urbana, Weldon Spring, West Des Moines, West Hills, Westlake, Wheat Ridge, and Ypsilanti, United StatesSee the 85 sites
- Phase
- Phase 2
Where in United States
- Southwest Gastroenterology AssociatesAlbuquerque, United StatesNo longer taking part
- Summit Clinical Research, LLCAthens, United StatesNo longer taking part
- DelRicht Clinical Research - AtlantaAtlanta, United StatesNo longer taking part
- University of Colorado AnschutzAurora, United StatesNo longer taking part
- Digestive Health - UT Health AustinAustin, United StatesNo longer taking part
- Gastro Health - BirminghamBirmingham, United StatesNo longer taking part
- Treasure Valley Medical ResearchBoise, United StatesNo longer taking part
- Connecticut Clinical Research Institute, LLCBristol, United StatesNo longer taking part
- NY ScientificBrooklyn, United StatesNo longer taking part
- Hope Clinical Research, LLCCanoga Park, United StatesNo longer taking part
- American Family Research GroupCape Coral, United StatesNo longer taking part
- Westchester Putnam GastroCarmel, United StatesNo longer taking part
- Atrium Health - Center for Gastroenterology and Hepatology MMPCharlotte, United StatesNo longer taking part
- Capital Digestive Care - Chevy Chase Clinical ResearchChevy Chase, United StatesNo longer taking part
- Erick H. Alayo Medical CorporationChula Vista, United StatesNo longer taking part
- Hometown Urgent Care and Research (Cincinnati)Cincinnati, United StatesNo longer taking part
- Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - ColumbusColumbus, United StatesNo longer taking part
- Flourish Research - Los Angeles (Covina)Covina, United StatesNo longer taking part
- Zenos Clinical ResearchDallas, United StatesNo longer taking part
- Epic Medical ResearchDeSoto, United StatesNo longer taking part
- Unique Clinical TrialsDoral, United StatesNo longer taking part
- USA and International Research Inc.Doral, United StatesNo longer taking part
- Cross Creek Medical Clinic, PAFayetteville, United StatesNo longer taking part
- Aa Mrc LlcFlint, United StatesNo longer taking part
- Gastrointestinal Associates and Endoscopy Center, PA - FlowoodFlowood, United StatesNo longer taking part
- G & L Research LLCFoley, United StatesNo longer taking part
- Gastro Health - FraminghamFramingham, United StatesNo longer taking part
- Sanmora Bespoke: Parkway Medical AssociationGlen Burnie, United StatesNo longer taking part
- Carolina Digestive Diseases & Endoscopy CenterGreenville, United StatesNo longer taking part
- GI Alliance GurneeGurnee, United StatesNo longer taking part
- Susquehanna Research Group, LLCHarrisburg, United StatesNo longer taking part
- Peters Medical ResearchHigh Point, United StatesNo longer taking part
- Galen Medical GroupHixson, United StatesNo longer taking part
- Advanced Medical Research GroupHollywood, United StatesNo longer taking part
- Amir A Hassan, MD, PAHouston, United StatesNo longer taking part
- Pioneer Research Solutions, Inc.Houston, United StatesNo longer taking part
- Hometown Urgent Care and Research - Huber HeightsHuber Heights, United StatesNo longer taking part
- Nature Coast Clinical ResearchInverness, United StatesNo longer taking part
- ENCORE Borland Groover Clinical ResearchJacksonville, United StatesNo longer taking part
- Rocky Mountain Gastroenterology (RMG)Lakewood, United StatesNo longer taking part
- Gastro Care InstituteLancaster, United StatesNo longer taking part
- Digestive Disease SpecialistsLas Vegas, United StatesNo longer taking part
- Excel Clinical ResearchLas Vegas, United StatesNo longer taking part
- Epic Clinical ResearchLewisville, United StatesNo longer taking part
- Applied Research Center of Arkansas, IncLittle Rock, United StatesNo longer taking part
- Preferred Research Partners, IncLittle Rock, United StatesNo longer taking part
- Downtown L.A. Research Center, Inc.Los Angeles, United StatesNo longer taking part
- University of LouisvilleLouisville, United StatesNo longer taking part
- Manassas Clinical Research CenterManassas, United StatesNo longer taking part
- Gastrointestinal Specialists of Georgia, PCMarietta, United StatesNo longer taking part
- Tandem Clinical ResearchMarrero, United StatesNo longer taking part
- Allied Biomedical Research Institute, IncMiami, United StatesNo longer taking part
- Advocate Aurora Health Research InstituteMilwaukee, United StatesNo longer taking part
- Delta Research Partners of West Monroe, LLCMonroe, United StatesNo longer taking part
- NOLA Research WorksNew Orleans, United StatesNo longer taking part
- Advanced Research Institute, Inc.New Port Richey, United StatesNo longer taking part
- Capital Digestive CenterNorfolk, United StatesNo longer taking part
- North Hills Medical Research Inc. (North Hills Family Medicine)North Richland Hills, United StatesNo longer taking part
- Sensible Healthcare, LLCOcoee, United StatesNo longer taking part
- Advanced Research Institute OgdenOgden, United StatesNo longer taking part
- Quality Clinical Research, Inc.Omaha, United StatesNo longer taking part
- Temple University HospitalPhiladelphia, United StatesNo longer taking part
- Advanced Research Institute - PortlandPortland, United StatesNo longer taking part
- Portland Gastroenterology AssociatesPortland, United StatesNo longer taking part
- Advanced Research Institute - RenoReno, United StatesNo longer taking part
- Bandera Family HealthCare Research, LLC (BFHC)San Antonio, United StatesNo longer taking part
- Acclaim Clinical ResearchSan Diego, United StatesNo longer taking part
- GI Alliance - Texas Digestive Disease Consultants - San MarcosSan Marcos, United StatesNo longer taking part
- Advanced Research Institute - SandySandy City, United StatesNo longer taking part
- The Center for Clinical TrialsSaraland, United StatesNo longer taking part
- Frontier Clinical Research, LLC - SmithfieldSmithfield, United StatesNo longer taking part
- KAD Clinical Research, LLCSt Louis, United StatesNo longer taking part
- GCP ResearchSt. Petersburg, United StatesNo longer taking part
- PPCP Division of GastroenterologySummerville, United StatesNo longer taking part
- Texas Digestive SpecialistsTexas City, United StatesNo longer taking part
- Kansas Medical Clinic, P.A.Topeka, United StatesNo longer taking part
- Del Sol Research Management, LLCTucson, United StatesNo longer taking part
- Options Health ResearchTulsa, United StatesNo longer taking part
- Carle Clinic - Urbana MainUrbana, United StatesNo longer taking part
- St. Charles Clinical ResearchWeldon Spring, United StatesNo longer taking part
- Integrated Clinical Trial Services, Inc.West Des Moines, United StatesNo longer taking part
- Focus Clinical Research - West HillsWest Hills, United StatesNo longer taking part
- Gastro Intestinal Research Institute of Northern Ohio, LLCWestlake, United StatesNo longer taking part
- Paradigm Research - WheatridgeWheat Ridge, United StatesNo longer taking part
- Huron GastroenterologyYpsilanti, United StatesNo longer taking part
Trial details
- Who runs it
- CinDome Pharma, Inc.
- Trial code
- NCT06899217
- Record updated
- 13 July 2026
- Original 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.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
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
Inclusion: Is a male or female ≥18 years of age; Has a current diagnosis of gastroparesis defined by the following:; Persistent gastrointestinal (GI) 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) at Visit 2; Body mass index between 17 and 49 kg/m2, inclusive; 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:; Is not taking the agent(s) for the management of diabetes or blood glucose; 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; Is tolerating the agent(s) well, according to the Investigator's judgment; In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and; Symptoms of gastroparesis were present before starting the agent(s); -------------------------------------------------------------------------.
Exclusion: Has been hospitalized for gastroparesis or malnutrition within 3 months prior to Screening; 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; 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; 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.]); Has a current diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association. Pre-diabetes is not exclusionary; Has a history of pyloric injection of botulinum toxin within 6 months of Screening or planned injection(s) during the study; Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy (G-POEM) procedure; Has a history of gastric surgery; Has a history of or current diagnosis of intestinal malabsorption, recurrent or chronic pancreatitis, or other pancreatic exocrine disease; Has a history of severe and refractory constipation; Has a history or evidence of clinically significant arrhythmia; Has a substance use disorder or a positive alcohol or positive drug screen.