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Trial record 1 of 2 for:    CIN-102
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A Scintigraphy Study in Adults With Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT04208698
Recruitment Status : Terminated (Trial was terminated due to the impact of COVID-19 on trial activities.)
First Posted : December 23, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
CinDome Pharma, Inc.

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
Diabetic Gastroparesis 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.

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Study Type : Interventional  (Clinical Trial)
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 : February 17, 2020
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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




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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline to Day 14 ]
  4. To asses the change from baseline in ANMS GCSI-DD total scores [ Time Frame: Day -14 to 14 ]
  5. To assess the change from baseline in ANMS GCSI-DD subscale scores [ Time Frame: Day -14 to 14 ]
  6. To assess the change from baseline in symptom severity as measured by the PAGI-SYM [ Time Frame: Baseline to Day 14 ]
  7. To assess the change in baseline of the Clinical Grading Assessment Scale [ Time Frame: Baseline to Day 14 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208698


Locations
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United States, Texas
Research Site
El Paso, Texas, United States, 79905
Sponsors and Collaborators
CinDome Pharma, Inc.
Investigators
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Study Director: Brian Murphy, MD, MPH CinRx Pharma
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Responsible Party: CinDome Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04208698    
Other Study ID Numbers: CIN-102-122
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations