Phase
Condition
Dysmenorrhea (Painful Periods)
Lactose Intolerance
Colic
Treatment
CIN-102 Dose 15mg
Placebo
CIN-102 Dose 10mg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
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 theInvestigator, are consistent with gastroparesis within 6 months prior toScreening; and
Documented delayed gastric emptying as determined by gastric emptying breathtest (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 andmarketed glucagon-like peptide-1 receptor agonist (GLP-1RA) for weight loss orreduce risk of major adverse cardiovascular events, and/or, receiving any otheragent(s) taken for weight loss, subjects may be considered for the study if ALL ofthe 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 beforeScreening 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 ofgastroparesis are NOT solely due to the the agent(s); and
Symptoms of gastroparesis were present before starting the agent(s).
Exclusion
Key Exclusion Criteria:
Has a known primary cause of gastroparesis (eg, diabetes, surgery; acute, ongoing,or active viral illness; cancer, medications, musculoskeletal or connective tissuedisorders [eg, scleroderma, systemic lupus erythematosus], or other neurologicdisorder [eg, Parkinson's disease], postural orthostatic tachycardia syndrome (POTS), etc.]);
Has a current diagnosis of Type 1 or Type 2 diabetes, according to the AmericanDiabetes Association. Pre-diabetes is not exclusionary;
Has been hospitalized for gastroparesis or malnutrition within 3 months prior toScreening;
Has a known or suspected GI mechanical obstruction (eg, peptic stricture) asdocumented by upper GI endoscopy, upper GI radiographic series, plain film abdomenX-ray, or computed tomography (CT) in the past 2 years prior to Randomization;
Has a history of pyloric injection of botulinum toxin within 6 months of Screeningor planned injection(s) during the study;
Has any history of pyloroplasty, pyloromyotomy, or gastric peroral endoscopicmyotomy (G-POEM) procedure;
Has a history of gastric surgery;
Has a history of or current diagnosis of intestinal malabsorption, recurrent orchronic pancreatitis, or other pancreatic exocrine disease;
Has a history of severe and refractory constipation;
Has a history or evidence of clinically significant arrhythmia;
Currently receiving parenteral feeding or presence of a nasogastric or other gastricenteral tube (e.g. percutaneous endoscopic gastrostomy [PEG] or percutaneousendoscopic jejunostomy [PEJ] tube) for feeding or decompression; Note: patientsreceiving enteral feeding via a jejunostomy tube may be included if, in the opinionof the Investigator, the patient is also taking substantial oral solid intake andare not primarily dependent on enteral nutrition
Has a substance use disorder or a positive alcohol or positive drug screen.
Study Design
Connect with a study center
G & L Research, LLC
Foley, Alabama 36535
United StatesSite Not Available
The Center for Clinical Trials
Saraland, Alabama 36571
United StatesSite Not Available
Gastro Health - Birmingham
Birmingham 4049979, Alabama 4829764 35235
United StatesActive - Recruiting
G & L Research, LLC
Foley 4062644, Alabama 4829764 36535
United StatesActive - Recruiting
The Center for Clinical Trials
Saraland 4088628, Alabama 4829764 36571
United StatesActive - Recruiting
Del Sol Research Management, LLC
Tucson, Arizona 85715
United StatesSite Not Available
Del Sol Research Management, LLC
Tucson 5318313, Arizona 5551752 85715
United StatesActive - Recruiting
Applied Research Center of Arkansas, Inc
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Preferred Research Partners, Inc.
Little Rock, Arkansas 72211
United StatesSite Not Available
Applied Research Center of Arkansas, Inc
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
Preferred Research Partners, Inc.
Little Rock 4119403, Arkansas 4099753 72211
United StatesActive - Recruiting
Hope Clinical Research LLC
Canoga Park, California 91303
United StatesSite Not Available
Erick H. Alayo Medical Corporation
Chula Vista, California 91910
United StatesSite Not Available
Flourish Research - Los Angeles (Covina)
Covina, California 91723
United StatesSite Not Available
Gastro Care Institute
Lancaster, California 93534
United StatesSite Not Available
Downtown L.A. Research Center, Inc.
Los Angeles, California 90017
United StatesSite Not Available
Acclaim Clinical Research
San Diego, California 92120
United StatesSite Not Available
Focus Clinical Research - West Hills
West Hills, California 91307
United StatesSite Not Available
Hope Clinical Research LLC
Canoga Park 5333913, California 5332921 91303
United StatesActive - Recruiting
Erick H. Alayo Medical Corporation
Chula Vista 5336899, California 5332921 91910
United StatesActive - Recruiting
Flourish Research - Los Angeles (Covina)
Covina 5340175, California 5332921 91723
United StatesActive - Recruiting
Gastro Care Institute
Lancaster 5364940, California 5332921 93534
United StatesActive - Recruiting
Downtown L.A. Research Center, Inc.
Los Angeles 5368361, California 5332921 90017
United StatesActive - Recruiting
Acclaim Clinical Research
San Diego 5391811, California 5332921 92120
United StatesActive - Recruiting
Focus Clinical Research - West Hills
West Hills 8030162, California 5332921 91307
United StatesActive - Recruiting
Rocky Mountain Gastroenterology (RMG)
Lakewood, Colorado 80228
United StatesSite Not Available
Paradigm Research - Wheatridge
Wheat Ridge, Colorado 80033
United StatesSite Not Available
University of Colorado Anschutz
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Rocky Mountain Gastroenterology (RMG)
Lakewood 5427946, Colorado 5417618 80228
United StatesActive - Recruiting
Paradigm Research - Wheatridge
Wheat Ridge 5443948, Colorado 5417618 80033
United StatesActive - Recruiting
Connecticut Clinical Research Institute, LLC
Bristol, Connecticut 06010
United StatesSite Not Available
Connecticut Clinical Research Institute, LLC
Bristol 5282835, Connecticut 4831725 06010
United StatesActive - Recruiting
American Family Research Group
Cape Coral, Florida 33909
United StatesSite Not Available
USA and International Research Inc.
Doral, Florida 33126
United StatesSite Not Available
Unique Clinical Trials
Doral, Florida 33172
United StatesActive - Recruiting
Advanced Medical Research Group
Hollywood, Florida 33021
United StatesSite Not Available
Nature Coast Clinical Research
Inverness, Florida 34452
United StatesSite Not Available
ENCORE Borland Groover Clinical Research
Jacksonville, Florida 32256
United StatesSite Not Available
Allied Biomedical Research Institute, Inc.
Miami, Florida 33155
United StatesSite Not Available
Advanced Research Institute Inc
New Port Richey, Florida 34653
United StatesSite Not Available
Sensible Healthcare, LLC
Ocoee, Florida 34761
United StatesSite Not Available
GCP Research
Saint Petersburg, Florida 33705
United StatesSite Not Available
American Family Research Group
Cape Coral 4149962, Florida 4155751 33909
United StatesActive - Recruiting
USA and International Research Inc.
Doral 4153471, Florida 4155751 33126
United StatesActive - Recruiting
Unique Clinical Trials
Doral 4153471, Florida 4155751 33172
United StatesActive - Recruiting
Advanced Medical Research Group
Hollywood 4158928, Florida 4155751 33021
United StatesActive - Recruiting
Nature Coast Clinical Research
Inverness 4159786, Florida 4155751 34452
United StatesActive - Recruiting
ENCORE Borland Groover Clinical Research
Jacksonville 4160021, Florida 4155751 32256
United StatesActive - Recruiting
Allied Biomedical Research Institute, Inc.
Miami 4164138, Florida 4155751 33155
United StatesActive - Recruiting
Advanced Research Institute Inc
New Port Richey 4165869, Florida 4155751 34653
United StatesActive - Recruiting
Sensible Healthcare, LLC
Ocoee 4166776, Florida 4155751 34761
United StatesActive - Recruiting
GCP Research
St. Petersburg 4171563, Florida 4155751 33705
United StatesActive - Recruiting
Summit Clinical Research, LLC
Athens, Georgia 30607
United StatesSite Not Available
DelRicht Clinical Research - Atlanta
Atlanta, Georgia 30329
United StatesSite Not Available
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia 30060
United StatesSite Not Available
Summit Clinical Research, LLC
Athens 4180386, Georgia 4197000 30607
United StatesActive - Recruiting
DelRicht Clinical Research - Atlanta
Atlanta 4180439, Georgia 4197000 30329
United StatesActive - Recruiting
Gastrointestinal Specialists of Georgia PC
Marietta 4207783, Georgia 4197000 30060
United StatesActive - Recruiting
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesSite Not Available
Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706
United StatesActive - Recruiting
GI Alliance - Gurnee
Gurnee, Illinois 60031
United StatesSite Not Available
GI Alliance - Gurnee
Gurnee 4894861, Illinois 4896861 60031
United StatesActive - Recruiting
Carle Clinic - Urbana Main
Urbana 4914570, Illinois 4896861 61801
United StatesActive - Recruiting
Integrated Clinical Trial Services, Inc
West Des Moines, Iowa 50265
United StatesSite Not Available
Integrated Clinical Trial Services, Inc
West Des Moines 4881346, Iowa 4862182 50265
United StatesActive - Recruiting
Kansas Medical Clinic, P.A.
Topeka, Kansas 66606
United StatesSite Not Available
Kansas Medical Clinic, P.A.
Topeka 4280539, Kansas 4273857 66606
United StatesActive - Recruiting
University of Louisville
Louisville 4299276, Kentucky 6254925 40202
United StatesActive - Recruiting
Tandem Clinical Research
Marrero, Louisiana 70072
United StatesSite Not Available
Delta Research Partners of West Monroe, LLC
Monroe, Louisiana 71201
United StatesSite Not Available
NOLA Research Works
New Orleans, Louisiana 70125
United StatesSite Not Available
Tandem Clinical Research
Marrero 4332628, Louisiana 4331987 70072
United StatesActive - Recruiting
Delta Research Partners of West Monroe, LLC
Monroe 4333669, Louisiana 4331987 71201
United StatesActive - Recruiting
NOLA Research Works
New Orleans 4335045, Louisiana 4331987 70125
United StatesActive - Recruiting
Portland Gastroenterology Associates
Portland, Maine 04101
United StatesSite Not Available
Portland Gastroenterology Associates
Portland 4975802, Maine 4971068 04101
United StatesActive - Recruiting
Capital Digestive Care - Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Sanmora Bespoke: Parkway Medical Association
Glen Burnie, Maryland 21061
United StatesSite Not Available
Capital Digestive Care - Chevy Chase Clinical Research
Chevy Chase 4351335, Maryland 4361885 20815
United StatesActive - Recruiting
Sanmora Bespoke: Parkway Medical Association
Glen Burnie 4356188, Maryland 4361885 21061
United StatesActive - Recruiting
Gastro Health - Framingham
Framingham, Massachusetts 01702
United StatesSite Not Available
Gastro Health - Framingham
Framingham 4937230, Massachusetts 6254926 01702
United StatesActive - Recruiting
Aa Mrc, Llc
Flint, Michigan 48504
United StatesSite Not Available
Huron Gastroenterology
Ypsilanti, Michigan 48197
United StatesSite Not Available
Aa Mrc, Llc
Flint 4992982, Michigan 5001836 48504
United StatesActive - Recruiting
Huron Gastroenterology
Ypsilanti 5015688, Michigan 5001836 48197
United StatesActive - Recruiting
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood, Mississippi 39232
United StatesSite Not Available
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood 4426822, Mississippi 4436296 39232
United StatesActive - Recruiting
St. Charles Clinical Research
Weldon Spring, Missouri 63304
United StatesSite Not Available
KAD Clinical Research, LLC
St Louis 4407066, Missouri 4398678 63123
United StatesActive - Recruiting
St. Charles Clinical Research
Weldon Spring 4413926, Missouri 4398678 63304
United StatesActive - Recruiting
Quality Clinical Research, Inc
Omaha, Nebraska 68114
United StatesSite Not Available
Quality Clinical Research, Inc
Omaha 5074472, Nebraska 5073708 68114
United StatesActive - Recruiting
Digestive Disease Specialists
Las Vegas, Nevada 89128
United StatesSite Not Available
Excel Clinical Research
Las Vegas, Nevada 89109
United StatesActive - Recruiting
Advanced Research Institute - Reno
Reno, Nevada 89511
United StatesSite Not Available
Digestive Disease Specialists
Las Vegas 5506956, Nevada 5509151 89128
United StatesActive - Recruiting
Excel Clinical Research
Las Vegas 5506956, Nevada 5509151 89109
United StatesActive - Recruiting
Advanced Research Institute - Reno
Reno 5511077, Nevada 5509151 89511
United StatesActive - Recruiting
Southwest Gastroenterology Associates
Albuquerque, New Mexico 87109
United StatesSite Not Available
Southwest Gastroenterology Associates
Albuquerque 5454711, New Mexico 5481136 87109
United StatesActive - Recruiting
NY Scientific
Brooklyn, New York 11235
United StatesSite Not Available
Westchester Putnam Gastro
Carmel, New York 10512
United StatesSite Not Available
NY Scientific
Brooklyn 5110302, New York 5128638 11235
United StatesActive - Recruiting
Westchester Putnam Gastro
Carmel 5111576, New York 5128638 10512
United StatesActive - Recruiting
Cross Creek Medical Clinic, PA
Fayetteville, North Carolina 28304
United StatesSite Not Available
Carolina Digestive Diseases & Endoscopy Center
Greenville, North Carolina 27834
United StatesSite Not Available
Peters Medical Research
High Point, North Carolina 27260
United StatesSite Not Available
Atrium Health - Center for Gastroenterology and Hepatology MMP
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Cross Creek Medical Clinic, PA
Fayetteville 4466033, North Carolina 4482348 28304
United StatesActive - Recruiting
Carolina Digestive Diseases & Endoscopy Center
Greenville 4469160, North Carolina 4482348 27834
United StatesActive - Recruiting
Peters Medical Research
High Point 4471025, North Carolina 4482348 27260
United StatesActive - Recruiting
Hometown Urgent Care and Research (Cincinnati)
Cincinnati, Ohio 45150
United StatesSite Not Available
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus
Columbus, Ohio 43228
United StatesSite Not Available
Hometown Urgent Care and Research - Huber Heights
Huber Heights, Ohio 45424
United StatesSite Not Available
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio 44145
United StatesSite Not Available
Hometown Urgent Care and Research (Cincinnati)
Cincinnati 4508722, Ohio 5165418 45150
United StatesActive - Recruiting
Urgent Care Specialists, LLC DBA Hometown Urgent Care and Occupational Health - Columbus
Columbus 4509177, Ohio 5165418 43228
United StatesActive - Recruiting
Hometown Urgent Care and Research - Huber Heights
Huber Heights 4514746, Ohio 5165418 45424
United StatesActive - Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake 5176517, Ohio 5165418 44145
United StatesActive - Recruiting
Options Health Research
Tulsa, Oklahoma 74104
United StatesSite Not Available
Options Health Research
Tulsa 4553433, Oklahoma 4544379 74104
United StatesActive - Recruiting
Advanced Research Institute - Portland
Portland 5746545, Oregon 5744337 97223
United StatesActive - Recruiting
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
United StatesSite Not Available
Frontier Clinical Research, LLC - Smithfield
Smithfield, Pennsylvania 15478
United StatesSite Not Available
Susquehanna Research Group, LLC
Harrisburg 5192726, Pennsylvania 6254927 17110
United StatesActive - Recruiting
Temple University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesActive - Recruiting
Frontier Clinical Research, LLC - Smithfield
Smithfield 4561301, Pennsylvania 6254927 15478
United StatesActive - Recruiting
PPCP Division of Gastroenterology
Summerville, South Carolina 29486
United StatesSite Not Available
PPCP Division of Gastroenterology
Summerville 4597919, South Carolina 4597040 29486
United StatesActive - Recruiting
Galen Medical Group
Hixson, Tennessee 37343
United StatesSite Not Available
Galen Medical Group
Hixson 4629825, Tennessee 4662168 37343
United StatesActive - Recruiting
Digestive Health - UT Health Austin
Austin, Texas 78712
United StatesSite Not Available
Zenos Clinical Research
Dallas, Texas 75230
United StatesSite Not Available
EPIC Medical Research
DeSoto, Texas 75115
United StatesSite Not Available
Pioneer Research Solutions Inc.
Houston, Texas 77099
United StatesSite Not Available
Epic Clinical Research
Lewisville, Texas 75057
United StatesSite Not Available
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills, Texas 76180
United StatesSite Not Available
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio, Texas 78249
United StatesSite Not Available
GI Alliance - Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas 78666
United StatesSite Not Available
Digestive Health - UT Health Austin
Austin 4671654, Texas 4736286 78712
United StatesActive - Recruiting
Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
EPIC Medical Research
DeSoto 4685524, Texas 4736286 75115
United StatesActive - Recruiting
Amir A Hassan, MD, PA
Houston 4699066, Texas 4736286 77089
United StatesActive - Recruiting
Pioneer Research Solutions Inc.
Houston 4699066, Texas 4736286 77099
United StatesActive - Recruiting
Epic Clinical Research
Lewisville 4706057, Texas 4736286 75057
United StatesActive - Recruiting
North Hills Medical Research Inc. (North Hills Family Medicine)
North Richland Hills 4715292, Texas 4736286 76180
United StatesActive - Recruiting
Bandera Family HealthCare Research, LLC (BFHC)
San Antonio 4726206, Texas 4736286 78249
United StatesActive - Recruiting
GI Alliance - Texas Digestive Disease Consultants - San Marcos
San Marcos 4726491, Texas 4736286 78666
United StatesActive - Recruiting
Texas Digestive Specialists
Texas City 4736134, Texas 4736286 78550
United StatesActive - Recruiting
Advanced Research Institute - Ogden
Ogden, Utah 84405
United StatesSite Not Available
Advanced Research Institute - Ogden
Ogden 5779206, Utah 5549030 84405
United StatesActive - Recruiting
Advanced Research Institute - Sandy
Sandy City 5781061, Utah 5549030 84092
United StatesActive - Recruiting
Manassas Clinical Research Center
Manassas, Virginia 20110
United StatesSite Not Available
Manassas Clinical Research Center
Manassas 4771401, Virginia 6254928 20110
United StatesActive - Recruiting
Capital Digestive Center
Norfolk 4776222, Virginia 6254928 23502
United StatesActive - Recruiting
Advocate Aurora Health Research Institute
Milwaukee 5263045, Wisconsin 5279468 53215
United StatesActive - Recruiting
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