A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
A legfontosabb adatok
- Hol
- Arlington, Athens, Bastrop, Bell Gardens, Bountiful, Brooklyn, Canoga Park, Charlotte, Chattanooga, Chesterfield, Chula Vista, Clearwater, Cleveland, Columbus, Corona, Costa Mesa, Dallas, Decatur, Denver, Doral, Dothan, East Syracuse, El Paso, Englewood, Evansville, Fayetteville, Flint, Foley, Fort Wayne, Freehold, Garden Grove, Greensboro, Harrisburg, Henderson, High Point, Hollywood, Houma, Houston, Huntsville, Inverness, Jackson, Kansas City, Las Vegas, Lewisville, Little Rock, Lomita, Los Angeles, Louisville, Lubbock, Maitland, Manassas, Marrero, Mason, McAllen, McKinney, Medford, Metairie, Miami, Milwaukee, Mission Hills, Missoula, New Port Richey, New York, North Little Rock, Orange City, Overland Park, Peoria, Phoenix, Raleigh, Richmond Hill, San Antonio, Spring, St Louis, Thousand Oaks, Topeka, Troy, Tucson, Tulsa, Viera, Weldon Spring, West Jordan, Westlake, Wichita és Wyoming (Egyesült Államok)Mind a 100 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- North Hills Medical Research Inc. (North Hills Familiy Medicine)Arlington, Egyesült ÁllamokNo longer taking part
- Summit Clinical Research, LLCAthens, Egyesült ÁllamokNo longer taking part
- Delta Research PartnersBastrop, Egyesült ÁllamokNo longer taking part
- Alliance Research Institute - Bell GardensBell Gardens, Egyesült ÁllamokNo longer taking part
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- NY ScientificBrooklyn, Egyesült ÁllamokNo longer taking part
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- Atrium Health Center for Digestive HealthCharlotte, Egyesült ÁllamokNo longer taking part
- Onsite Clinical Solutions, LLCCharlotte, Egyesült ÁllamokNo longer taking part
- Galen Medical Group - Downtown Gastroenterology LocationChattanooga, Egyesült ÁllamokNo longer taking part
- WR-ClinSearchChattanooga, Egyesült ÁllamokNo longer taking part
- Clinical Research Institute of Michigan, LLCChesterfield, Egyesült ÁllamokNo longer taking part
- Erick H. Alayo Medical CorporationChula Vista, Egyesült ÁllamokNo longer taking part
- GW Research IncChula Vista, Egyesült ÁllamokNo longer taking part
- Innovative Research of West FloridaClearwater, Egyesült ÁllamokNo longer taking part
- Cleveland ClinicCleveland, Egyesült ÁllamokNo longer taking part
- Remington Davis, Inc.Columbus, Egyesült ÁllamokNo longer taking part
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- New Hope Research DevelopmentCorona, Egyesült ÁllamokNo longer taking part
- Aurora Care ClinicCosta Mesa, Egyesült ÁllamokNo longer taking part
- Zenos Clinical ResearchDallas, Egyesült ÁllamokNo longer taking part
- Atlanta Center For Gastroenterology, P.C.Decatur, Egyesült ÁllamokNo longer taking part
- Research Carolina Elite LLCDenver, Egyesült ÁllamokNo longer taking part
- USA and International Research Inc.Doral, Egyesült ÁllamokNo longer taking part
- Digestive Health Specialists of the SoutheastDothan, Egyesült ÁllamokNo longer taking part
- Velocity Clinical Research, SyracuseEast Syracuse, Egyesült ÁllamokNo longer taking part
- Texas Gastro Research, LLCEl Paso, Egyesült ÁllamokNo longer taking part
- Allied Health Clinical Research Organization, LLC (AHCRO) - EnglewoodEnglewood, Egyesült ÁllamokNo longer taking part
- Medisphere Medical Research CenterEvansville, Egyesült ÁllamokNo longer taking part
- Coastal Research Institute, LLCFayetteville, Egyesült ÁllamokNo longer taking part
- Cross Creek Medical, PAFayetteville, Egyesült ÁllamokNo longer taking part
- Aa Mrc LlcFlint, Egyesült ÁllamokNo longer taking part
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- Lutheran Medical GroupFort Wayne, Egyesült ÁllamokNo longer taking part
- Allied Health Clinical Research Organization, LLC (AHCRO) - FreeholdFreehold, Egyesült ÁllamokNo longer taking part
- Paragon Rx ClinicalGarden Grove, Egyesült ÁllamokNo longer taking part
- Valley View Wellness and Medical Center - VVCRDGarden Grove, Egyesült ÁllamokNo longer taking part
- Triad Clinical Trials, LLCGreensboro, Egyesült ÁllamokNo longer taking part
- Susquehanna Research Group, LLCHarrisburg, Egyesült ÁllamokNo longer taking part
- DelRicht Clinical Research - NashvilleHenderson, Egyesült ÁllamokNo longer taking part
- Peters Medical ResearchHigh Point, Egyesült ÁllamokNo longer taking part
- Advanced Medical Research GroupHollywood, Egyesült ÁllamokNo longer taking part
- Tandem Clinical Research GI - HoumaHouma, Egyesült ÁllamokNo longer taking part
- Amir A Hassan, MD, PAHouston, Egyesült ÁllamokNo longer taking part
- Care and Cure ClinicHouston, Egyesült ÁllamokNo longer taking part
- Houston Methodist Research InstituteHouston, Egyesült ÁllamokNo longer taking part
- Pioneer Research Solutions, Inc.Houston, Egyesült ÁllamokNo longer taking part
- Clinical Research Associates LLCHuntsville, Egyesült ÁllamokNo longer taking part
- Nature Coast Clinical ResearchInverness, Egyesült ÁllamokNo longer taking part
- Allied Health Clinical Research Organization, LLC (AHCRO) - JacksonJackson, Egyesült ÁllamokNo longer taking part
- Kansas City Research InstituteKansas City, Egyesült ÁllamokNo longer taking part
- University of Kansas Medical Center (KUMC)Kansas City, Egyesült ÁllamokNo longer taking part
- American Institute of Medical ResearchLas Vegas, Egyesült ÁllamokNo longer taking part
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- University of LouisvilleLouisville, Egyesült ÁllamokNo longer taking part
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- A+ Research, Inc.Miami, Egyesült ÁllamokNo longer taking part
- International Research Associates LLC - BretonMiami, Egyesült ÁllamokNo longer taking part
- Wisconsin Center for Advanced ResearchMilwaukee, Egyesült ÁllamokNo longer taking part
- Facey Medical ResearchMission Hills, Egyesült ÁllamokNo longer taking part
- Montana Medical Research, IncMissoula, Egyesült ÁllamokNo longer taking part
- Advanced Research Institute, Inc.New Port Richey, Egyesült ÁllamokNo longer taking part
- Tandem Clinical Research GI - New YorkNew York, Egyesült ÁllamokNo longer taking part
- Arkansas Gastroenterology - North Little RockNorth Little Rock, Egyesült ÁllamokNo longer taking part
- Gastroenterology of Greater OrlandoOrange City, Egyesült ÁllamokNo longer taking part
- DelRicht Clinical Research - Overland ParkOverland Park, Egyesült ÁllamokNo longer taking part
- Phoenix Medical Research Institute, LLCPeoria, Egyesült ÁllamokNo longer taking part
- Onyx Clinical ResearchPhoenix, Egyesült ÁllamokNo longer taking part
- Carolina's GI ResearchRaleigh, Egyesült ÁllamokNo longer taking part
- A1 Clinical NetworkRichmond Hill, Egyesült ÁllamokNo longer taking part
- Gastroenterology Research of San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
- A1 Clinical NetworkSpring, Egyesült ÁllamokNo longer taking part
- Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
- Millennium Clinical TrialsThousand Oaks, Egyesült ÁllamokNo longer taking part
- Kansas Medical Clinic, P.A.Topeka, Egyesült ÁllamokNo longer taking part
- Clinical Research Institute of Michigan, LLC - TroyTroy, Egyesült ÁllamokNo longer taking part
- Del Sol Research Management, LLCTucson, Egyesült ÁllamokNo longer taking part
- Options Health ResearchTulsa, Egyesült ÁllamokNo longer taking part
- Tandem Clinical Research - VieraViera, Egyesült ÁllamokNo longer taking part
- St. Charles Clinical ResearchWeldon Spring, Egyesült ÁllamokNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, Egyesült ÁllamokNo longer taking part
- Northshore Gastroenterology Research, LLCWestlake, Egyesült ÁllamokNo longer taking part
- Alliance for Multispecialty Research-Wichita WestWichita, Egyesült ÁllamokNo longer taking part
- Gastroenterology Associates of Western MichiganWyoming, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- CinDome Pharma, Inc.
- Azonosító
- NCT05832151
- A regiszteradat frissítve
- 2026. november 5.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
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
Bevonási feltételek: Is a male or female ≥18 years of age; 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:; Persistent gastrointestinal 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), 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:; The GLP-1 RA has been prescribed for the management of diabetes and not specifically for weight loss/weight management; 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; Is tolerating the GLP-1RA well based on Investigator's judgment; None of the study-qualifying signs/symptoms of gastroparesis are solely attributable to the use of GLP-1RA; and; The symptoms of gastroparesis preceded the initiation of GLP-1RA therapy; Willing to washout from ongoing treatment for gastroparesis.
Kizáró feltételek: Has been hospitalized within 3 months prior to Visit 1 for diabetic gastroparesis and/or diabetic ketoacidosis and/or malnutrition; Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression; Positive test for drugs of abuse; 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); History or evidence of clinically significant arrhythmia; History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery; Has a known allergy to eggs or spirulina; Pyloric injection of botulinum toxin within 6 months of Screening; Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.