Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CinDome Pharma, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is a male or female ≥18 years of age;
Has a current diagnosis of gastroparesis defined by the following:
1. Persistent gastrointestinal (GI) symptoms that, in the opinion of the Investigator, are consistent with gastroparesis within 6 months prior to Screening; and
2. 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:
1. Is not taking the agent(s) for the management of diabetes or blood glucose;
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;
3. Is tolerating the agent(s) well, according to the Investigator's judgment;
4. In the opinion of the Investigator, the study-qualifying signs/symptoms of gastroparesis are NOT solely due to the the agent(s); and
5. Symptoms of gastroparesis were present before starting the agent(s).
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 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;
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;
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 substance use disorder or a positive alcohol or positive drug screen.
Clareo Health | A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
