This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis.
This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis. The population for this study is adult patients 18 to 70 years old with Type 1 or Type 2 diabetes and a diagnosis of diabetic gastroparesis. The study will consist of two cohorts with approximately 15 subjects in each cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
Deuterated domperidone (deudomperidone)
Deuterated domperidone (deudomperidone)
Placebo
Research Site
El Paso, Texas, United States
To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis.
Time frame: Baseline to Day 14
To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events.
Time frame: Screening to Day 20
To Assess the Effect of CIN-102 on Antral Contractility as Measured by Dynamic Antral Scintigraphy (DAS), a Non-invasive Technique for the Assessment of Post-prandial Gastric Contractions Will be Used to Evaluate Antral Motility.
Time frame: Baseline to Day 14
To Assess the Effect of CIN-102 on Gastric Accommodation to be Evaluated Using Data Captured During the Total-stomach Gastric Emptying Study to Measure Food Retention in the Stomach During the First Two Post-prandial Hours.
Time frame: Baseline to Day 14
To Asses the Change From Baseline in ANMS GCSI-DD Total Scores
Time frame: Day -14 to 14
To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores
Time frame: Day -14 to 14
To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM
Time frame: Baseline to Day 14
To Assess the Change in Baseline of the Clinical Grading Assessment Scale
Time frame: Baseline to Day 14
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