A Scintigraphy Study in Adults With Diabetic Gastroparesis
Primary Purpose
Diabetic Gastroparesis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CIN-102 Dose 1
CIN-102 Dose 2
Placebo for CIN-102
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Male and female patients 18 to 70 years old, inclusive.
- Type 1 or Type 2 diabetes mellitus, according to American Diabetes Association criteria
- Current diagnosis of diabetic gastroparesis.
- Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive.
- Glycosylated hemoglobin level <11% at Screening.
- Willing to abstain from tobacco or nicotine-containing product use after midnight on the day of the DAS test and throughout the time that gastric emptying is being imaged.
- Willing to abstain from grapefruit, grapefruit products, star fruit, star fruit products, and Seville oranges from 72 hours prior to the Randomization Visit until end of study.
Exclusion Criteria:
- History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, and Torsades de Pointes. Patients with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded.
- Clinically significant bradycardia with a resting heart rate under 50 beats per minute, sinus node dysfunction, or heart block.
- Prolonged heart rate-corrected QT interval using Fridericia's formula (QTcF) (QTcF >450 msec for males or QTcF >470 msec for females) based on the average of triplicate ECGs.
- A personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias or family history of sudden death.
- Evidence (based on Screening or Baseline assessments) or history of clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies); surgical conditions; cancer (with the exception of basal or squamous cell carcinoma of the skin and cancer that resolved or has been in remission for >5 years prior to the Screening Visit); or any condition that, in the Investigator's opinion, might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug.
- History of prolactin-releasing pituitary tumor (ie, prolactinoma).
- Allergic to egg or intolerant to gluten.
- History of alcoholism or drug abuse within 2 years prior to dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
- Known or suspected gastric outlet obstruction (eg, peptic stricture) or other gastrointestinal mechanical obstruction.
- Known history or current diagnosis of intestinal malabsorption or pancreatic exocrine disease.
- History or presence of any medical condition or psychiatric disease, which, in the opinion of the Investigator, could interfere with the conduct of the study or would put the patient at unacceptable risk.
- Judged by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
CIN-102 Tablets Dose 1
Placebo for CIN-102 Dose 1
CIN-102 Dose 2
Placebo for CIN-102 Dose 2
Arm Description
CIN-102 tablets by mouth twice daily for 14 days
Placebo tablets by mouth twice daily for 14 days
CIN-102 tablets by mouth twice daily for 14 days
Placebo tablets by mouth twice daily for 14 days
Outcomes
Primary Outcome Measures
To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis.
Secondary Outcome Measures
To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events.
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.
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.
To Asses the Change From Baseline in ANMS GCSI-DD Total Scores
To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores
To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM
To Assess the Change in Baseline of the Clinical Grading Assessment Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04208698
Brief Title
A Scintigraphy Study in Adults With Diabetic Gastroparesis
Official Title
A Randomized, Double-Blind Placebo-Controlled Scintigraphy Study to Investigate the Effect of CIN-102 on Gastric Emptying and Antral Contractility in Adults With Diabetic Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Trial was terminated due to the impact of COVID-19 on trial activities.
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CinDome Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CIN-102 Tablets Dose 1
Arm Type
Experimental
Arm Description
CIN-102 tablets by mouth twice daily for 14 days
Arm Title
Placebo for CIN-102 Dose 1
Arm Type
Placebo Comparator
Arm Description
Placebo tablets by mouth twice daily for 14 days
Arm Title
CIN-102 Dose 2
Arm Type
Experimental
Arm Description
CIN-102 tablets by mouth twice daily for 14 days
Arm Title
Placebo for CIN-102 Dose 2
Arm Type
Placebo Comparator
Arm Description
Placebo tablets by mouth twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 1
Intervention Description
Deuterated domperidone (deudomperidone)
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 2
Intervention Description
Deuterated domperidone (deudomperidone)
Intervention Type
Drug
Intervention Name(s)
Placebo for CIN-102
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
To Asses the Change From Baseline in ANMS GCSI-DD Total Scores
Time Frame
Day -14 to 14
Title
To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores
Time Frame
Day -14 to 14
Title
To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM
Time Frame
Baseline to Day 14
Title
To Assess the Change in Baseline of the Clinical Grading Assessment Scale
Time Frame
Baseline to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients 18 to 70 years old, inclusive.
Type 1 or Type 2 diabetes mellitus, according to American Diabetes Association criteria
Current diagnosis of diabetic gastroparesis.
Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive.
Glycosylated hemoglobin level <11% at Screening.
Willing to abstain from tobacco or nicotine-containing product use after midnight on the day of the DAS test and throughout the time that gastric emptying is being imaged.
Willing to abstain from grapefruit, grapefruit products, star fruit, star fruit products, and Seville oranges from 72 hours prior to the Randomization Visit until end of study.
Exclusion Criteria:
History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, and Torsades de Pointes. Patients with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded.
Clinically significant bradycardia with a resting heart rate under 50 beats per minute, sinus node dysfunction, or heart block.
Prolonged heart rate-corrected QT interval using Fridericia's formula (QTcF) (QTcF >450 msec for males or QTcF >470 msec for females) based on the average of triplicate ECGs.
A personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias or family history of sudden death.
Evidence (based on Screening or Baseline assessments) or history of clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies); surgical conditions; cancer (with the exception of basal or squamous cell carcinoma of the skin and cancer that resolved or has been in remission for >5 years prior to the Screening Visit); or any condition that, in the Investigator's opinion, might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug.
History of prolactin-releasing pituitary tumor (ie, prolactinoma).
Allergic to egg or intolerant to gluten.
History of alcoholism or drug abuse within 2 years prior to dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
Known or suspected gastric outlet obstruction (eg, peptic stricture) or other gastrointestinal mechanical obstruction.
Known history or current diagnosis of intestinal malabsorption or pancreatic exocrine disease.
History or presence of any medical condition or psychiatric disease, which, in the opinion of the Investigator, could interfere with the conduct of the study or would put the patient at unacceptable risk.
Judged by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Murphy, MD, MPH
Organizational Affiliation
CinRx Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
12. IPD Sharing Statement
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A Scintigraphy Study in Adults With Diabetic Gastroparesis
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