A Scintigraphy Study in Adults With Diabetic Gastroparesis

Sponsor
CinDome Pharma, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04208698
Collaborator
(none)
2
1
4
1.4
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CIN-102 Dose 1
  • Drug: CIN-102 Dose 2
  • Drug: Placebo for CIN-102
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 17, 2020
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIN-102 Tablets Dose 1

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 1
Deuterated domperidone (deudomperidone)

Placebo Comparator: Placebo for CIN-102 Dose 1

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo for CIN-102
Placebo

Experimental: CIN-102 Dose 2

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 2
Deuterated domperidone (deudomperidone)

Placebo Comparator: Placebo for CIN-102 Dose 2

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo for CIN-102
Placebo

Outcome Measures

Primary Outcome Measures

  1. To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis. [Baseline to Day 14]

Secondary Outcome Measures

  1. To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events. [Screening to Day 20]

  2. 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. [Baseline to Day 14]

  3. 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. [Baseline to Day 14]

  4. To Asses the Change From Baseline in ANMS GCSI-DD Total Scores [Day -14 to 14]

  5. To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores [Day -14 to 14]

  6. To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM [Baseline to Day 14]

  7. To Assess the Change in Baseline of the Clinical Grading Assessment Scale [Baseline to Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site El Paso Texas United States 79905

Sponsors and Collaborators

  • CinDome Pharma, Inc.

Investigators

  • Study Director: Brian Murphy, MD, MPH, CinRx Pharma

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
CinDome Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT04208698
Other Study ID Numbers:
  • CIN-102-122
First Posted:
Dec 23, 2019
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Two patients entered the Screening Period. No patients were randomized to the Study Treatment Period.
Arm/Group Title Screening Period CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description Screening Period CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Period Title: Overall Study
STARTED 2 0 0 0 0
COMPLETED 0 0 0 0 0
NOT COMPLETED 2 0 0 0 0

Baseline Characteristics

Arm/Group Title Screening Period CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2 Total
Arm/Group Description Screening Period CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo Total of all reporting groups
Overall Participants 2 0 0 0 0 2
Age (Count of Participants)
<=18 years
0
0%
0
NaN
Between 18 and 65 years
2
100%
2
Infinity
>=65 years
0
0%
0
NaN
Sex: Female, Male (Count of Participants)
Female
1
50%
1
Infinity
Male
1
50%
1
Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
50%
1
Infinity
Not Hispanic or Latino
1
50%
1
Infinity
Unknown or Not Reported
0
0%
0
NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
NaN
0
NaN
0
NaN
0
NaN
0
0%
Asian
0
0%
0
NaN
0
NaN
0
NaN
0
NaN
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
NaN
0
NaN
0
NaN
0
NaN
0
0%
Black or African American
0
0%
0
NaN
0
NaN
0
NaN
0
NaN
0
0%
White
2
100%
0
NaN
0
NaN
0
NaN
0
NaN
2
100%
More than one race
0
0%
0
NaN
0
NaN
0
NaN
0
NaN
0
0%
Unknown or Not Reported
0
0%
0
NaN
0
NaN
0
NaN
0
NaN
0
0%
Region of Enrollment (participants) [Number]
United States
2
100%
2
Infinity

Outcome Measures

1. Primary Outcome
Title To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis.
Description
Time Frame Baseline to Day 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
2. Secondary Outcome
Title To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events.
Description
Time Frame Screening to Day 20

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
3. Secondary Outcome
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.
Description
Time Frame Baseline to Day 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
4. Secondary Outcome
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.
Description
Time Frame Baseline to Day 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
5. Secondary Outcome
Title To Asses the Change From Baseline in ANMS GCSI-DD Total Scores
Description
Time Frame Day -14 to 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
6. Secondary Outcome
Title To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores
Description
Time Frame Day -14 to 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
7. Secondary Outcome
Title To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM
Description
Time Frame Baseline to Day 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0
8. Secondary Outcome
Title To Assess the Change in Baseline of the Clinical Grading Assessment Scale
Description
Time Frame Baseline to Day 14

Outcome Measure Data

Analysis Population Description
No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
Measure Participants 0 0 0 0

Adverse Events

Time Frame Approximately one month.
Adverse Event Reporting Description No patients were randomized to the study treatment period.
Arm/Group Title CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Arm/Group Description CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 1: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo CIN-102 tablets by mouth twice daily for 14 days CIN-102 Dose 2: Deuterated domperidone (deudomperidone) Placebo tablets by mouth twice daily for 14 days Placebo for CIN-102: Placebo
All Cause Mortality
CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Serious Adverse Events
CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
CIN-102 Tablets Dose 1 Placebo for CIN-102 Dose 1 CIN-102 Dose 2 Placebo for CIN-102 Dose 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Director of Clinical Trials
Organization CinDome Pharma, Inc.
Phone 844-531-1834
Email info@cinrx.com
Responsible Party:
CinDome Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT04208698
Other Study ID Numbers:
  • CIN-102-122
First Posted:
Dec 23, 2019
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021