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Befejeződött2. fázis

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

A legfontosabb adatok

Ki végzi
CinDome Pharma, Inc.
Hol
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 és Ypsilanti (Egyesült Államok)Mind a 85 helyszín megnézése
Azonosító
Állapot
Befejeződött
Fázis
2. fázis
Résztvevők
416 fő vett részt
Kezdés
2025. jan. 29.
Befejezés
2026. máj. 7.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • CIN-102 Dose 15mg
  • Placebo
  • CIN-102 Dose 10mg
A regiszteradat frissítve
2026. július 13.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 16 feltétel megnézéseKevesebb

Ki vehet részt

  • 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); -------------------------------------------------------------------------

Ki nem vehet részt

  • 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

Helyszínek itt: Egyesült Államok

  • Southwest Gastroenterology AssociatesAlbuquerque, Egyesült ÁllamokNo longer taking part
  • Summit Clinical Research, LLCAthens, Egyesült ÁllamokNo longer taking part
  • DelRicht Clinical Research - AtlantaAtlanta, Egyesült ÁllamokNo longer taking part
  • University of Colorado AnschutzAurora, Egyesült ÁllamokNo longer taking part
  • Digestive Health - UT Health AustinAustin, Egyesült ÁllamokNo longer taking part
  • Gastro Health - BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
  • Treasure Valley Medical ResearchBoise, Egyesült ÁllamokNo longer taking part
  • Connecticut Clinical Research Institute, LLCBristol, Egyesült ÁllamokNo longer taking part
  • NY ScientificBrooklyn, Egyesült ÁllamokNo longer taking part
  • Hope Clinical Research, LLCCanoga Park, Egyesült ÁllamokNo longer taking part
  • American Family Research GroupCape Coral, Egyesült ÁllamokNo longer taking part
  • Westchester Putnam GastroCarmel, Egyesült ÁllamokNo longer taking part
  • Atrium Health - Center for Gastroenterology and Hepatology MMPCharlotte, Egyesült ÁllamokNo longer taking part
  • Capital Digestive Care - Chevy Chase Clinical ResearchChevy Chase, Egyesült ÁllamokNo longer taking part
  • Erick H. Alayo Medical CorporationChula Vista, Egyesült ÁllamokNo longer taking part
  • Hometown Urgent Care and Research (Cincinnati)Cincinnati, Egyesült ÁllamokNo longer taking part
  • Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - ColumbusColumbus, Egyesült ÁllamokNo longer taking part
  • Flourish Research - Los Angeles (Covina)Covina, Egyesült ÁllamokNo longer taking part
  • Zenos Clinical ResearchDallas, Egyesült ÁllamokNo longer taking part
  • Epic Medical ResearchDeSoto, Egyesült ÁllamokNo longer taking part
  • Unique Clinical TrialsDoral, Egyesült ÁllamokNo longer taking part
  • USA and International Research Inc.Doral, Egyesült ÁllamokNo longer taking part
  • Cross Creek Medical Clinic, PAFayetteville, Egyesült ÁllamokNo longer taking part
  • Aa Mrc LlcFlint, Egyesült ÁllamokNo longer taking part
  • Gastrointestinal Associates and Endoscopy Center, PA - FlowoodFlowood, Egyesült ÁllamokNo longer taking part
  • G & L Research LLCFoley, Egyesült ÁllamokNo longer taking part
  • Gastro Health - FraminghamFramingham, Egyesült ÁllamokNo longer taking part
  • Sanmora Bespoke: Parkway Medical AssociationGlen Burnie, Egyesült ÁllamokNo longer taking part
  • Carolina Digestive Diseases & Endoscopy CenterGreenville, Egyesült ÁllamokNo longer taking part
  • GI Alliance GurneeGurnee, Egyesült ÁllamokNo longer taking part
  • Susquehanna Research Group, LLCHarrisburg, Egyesült ÁllamokNo longer taking part
  • Peters Medical ResearchHigh Point, Egyesült ÁllamokNo longer taking part
  • Galen Medical GroupHixson, Egyesült ÁllamokNo longer taking part
  • Advanced Medical Research GroupHollywood, Egyesült ÁllamokNo longer taking part
  • Amir A Hassan, MD, PAHouston, Egyesült ÁllamokNo longer taking part
  • Pioneer Research Solutions, Inc.Houston, Egyesült ÁllamokNo longer taking part
  • Hometown Urgent Care and Research - Huber HeightsHuber Heights, Egyesült ÁllamokNo longer taking part
  • Nature Coast Clinical ResearchInverness, Egyesült ÁllamokNo longer taking part
  • ENCORE Borland Groover Clinical ResearchJacksonville, Egyesült ÁllamokNo longer taking part
  • Rocky Mountain Gastroenterology (RMG)Lakewood, Egyesült ÁllamokNo longer taking part
  • Gastro Care InstituteLancaster, Egyesült ÁllamokNo longer taking part
  • Digestive Disease SpecialistsLas Vegas, Egyesült ÁllamokNo longer taking part
  • Excel Clinical ResearchLas Vegas, Egyesült ÁllamokNo longer taking part
  • Epic Clinical ResearchLewisville, Egyesült ÁllamokNo longer taking part
  • Applied Research Center of Arkansas, IncLittle Rock, Egyesült ÁllamokNo longer taking part
  • Preferred Research Partners, IncLittle Rock, Egyesült ÁllamokNo longer taking part
  • Downtown L.A. Research Center, Inc.Los Angeles, Egyesült ÁllamokNo longer taking part
  • University of LouisvilleLouisville, Egyesült ÁllamokNo longer taking part
  • Manassas Clinical Research CenterManassas, Egyesült ÁllamokNo longer taking part
  • Gastrointestinal Specialists of Georgia, PCMarietta, Egyesült ÁllamokNo longer taking part
  • Tandem Clinical ResearchMarrero, Egyesült ÁllamokNo longer taking part
  • Allied Biomedical Research Institute, IncMiami, Egyesült ÁllamokNo longer taking part
  • Advocate Aurora Health Research InstituteMilwaukee, Egyesült ÁllamokNo longer taking part
  • Delta Research Partners of West Monroe, LLCMonroe, Egyesült ÁllamokNo longer taking part
  • NOLA Research WorksNew Orleans, Egyesült ÁllamokNo longer taking part
  • Advanced Research Institute, Inc.New Port Richey, Egyesült ÁllamokNo longer taking part
  • Capital Digestive CenterNorfolk, Egyesült ÁllamokNo longer taking part
  • North Hills Medical Research Inc. (North Hills Family Medicine)North Richland Hills, Egyesült ÁllamokNo longer taking part
  • Sensible Healthcare, LLCOcoee, Egyesült ÁllamokNo longer taking part
  • Advanced Research Institute OgdenOgden, Egyesült ÁllamokNo longer taking part
  • Quality Clinical Research, Inc.Omaha, Egyesült ÁllamokNo longer taking part
  • Temple University HospitalPhiladelphia, Egyesült ÁllamokNo longer taking part
  • Advanced Research Institute - PortlandPortland, Egyesült ÁllamokNo longer taking part
  • Portland Gastroenterology AssociatesPortland, Egyesült ÁllamokNo longer taking part
  • Advanced Research Institute - RenoReno, Egyesült ÁllamokNo longer taking part
  • Bandera Family HealthCare Research, LLC (BFHC)San Antonio, Egyesült ÁllamokNo longer taking part
  • Acclaim Clinical ResearchSan Diego, Egyesült ÁllamokNo longer taking part
  • GI Alliance - Texas Digestive Disease Consultants - San MarcosSan Marcos, Egyesült ÁllamokNo longer taking part
  • Advanced Research Institute - SandySandy City, Egyesült ÁllamokNo longer taking part
  • The Center for Clinical TrialsSaraland, Egyesült ÁllamokNo longer taking part
  • Frontier Clinical Research, LLC - SmithfieldSmithfield, Egyesült ÁllamokNo longer taking part
  • KAD Clinical Research, LLCSt Louis, Egyesült ÁllamokNo longer taking part
  • GCP ResearchSt. Petersburg, Egyesült ÁllamokNo longer taking part
  • PPCP Division of GastroenterologySummerville, Egyesült ÁllamokNo longer taking part
  • Texas Digestive SpecialistsTexas City, Egyesült ÁllamokNo longer taking part
  • Kansas Medical Clinic, P.A.Topeka, Egyesült ÁllamokNo longer taking part
  • Del Sol Research Management, LLCTucson, Egyesült ÁllamokNo longer taking part
  • Options Health ResearchTulsa, Egyesült ÁllamokNo longer taking part
  • Carle Clinic - Urbana MainUrbana, Egyesült ÁllamokNo longer taking part
  • St. Charles Clinical ResearchWeldon Spring, Egyesült ÁllamokNo longer taking part
  • Integrated Clinical Trial Services, Inc.West Des Moines, Egyesült ÁllamokNo longer taking part
  • Focus Clinical Research - West HillsWest Hills, Egyesült ÁllamokNo longer taking part
  • Gastro Intestinal Research Institute of Northern Ohio, LLCWestlake, Egyesült ÁllamokNo longer taking part
  • Paradigm Research - WheatridgeWheat Ridge, Egyesült ÁllamokNo longer taking part
  • Huron GastroenterologyYpsilanti, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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

A vizsgálat 3 csoportja

  • CIN-102: 15mgA vizsgált kezelés

    15 mg CIN-102, taken orally BID for 12 weeks

    Kezelés: CIN-102 Dose 15mg

  • CIN-102: 10mgA vizsgált kezelés

    10 mg CIN-102, taken orally BID for 12 weeks

    Kezelés: CIN-102 Dose 10mg

  • Placebo for CIN-102Placebo, összehasonlításként

    Placebo for CIN-102, taken orally BID for 12 weeks

    Kezelés: Placebo

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
A regiszteradat frissítve
2026. július 13.