Diabetic GastroparesisPhase 2NCT04208698
A Scintigraphy Study in Adults With Diabetic Gastroparesis
A Phase 2 study testing CIN-102 Dose 1 and CIN-102 Dose 2 in people with Diabetic Gastroparesis, run by CinDome Pharma, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- CIN-102 Dose 1 and CIN-102 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 31 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Gastroparesis
- Being tested
- CIN-102 Dose 1, CIN-102 Dose 2, Placebo for CIN-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIN-102 Dose 1Drug
Deuterated domperidone (deudomperidone)
CIN-102 Dose 2Drug
Deuterated domperidone (deudomperidone)
Placebo for CIN-102Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CIN-102 Tablets Dose 1 | Experimental | CIN-102 tablets by mouth twice daily for 14 days Receives: Drug: CIN-102 Dose 1 |
| Placebo for CIN-102 Dose 1 | Placebo comparator | Placebo tablets by mouth twice daily for 14 days Receives: Drug: Placebo for CIN-102 |
| CIN-102 Dose 2 | Experimental | CIN-102 tablets by mouth twice daily for 14 days Receives: Drug: CIN-102 Dose 2 |
| Placebo for CIN-102 Dose 2 | Placebo comparator | Placebo tablets by mouth twice daily for 14 days Receives: Drug: Placebo for CIN-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis.
Measured: Baseline to Day 14
Secondary outcomes (7)
To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 14
To Asses the Change From Baseline in ANMS GCSI-DD Total Scores
Measured: Day -14 to 14
To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores
Measured: Day -14 to 14
To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM
Measured: Baseline to Day 14
To Assess the Change in Baseline of the Clinical Grading Assessment Scale
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start17 Feb 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Trial was terminated due to the impact of COVID-19 on trial activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- CinDome Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Murphy, MD, MPH, Study director, CinRx Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208698
- Sponsor's protocol ID
- CIN-102-122
- Status last verified
- Aug 2021
- First submitted
- 12 Dec 2019
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04208698
- Acronym / sponsor ID
- CIN-102-122
- Conditions
- Diabetic Gastroparesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated due to the impact of COVID-19 on trial activities.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CinDome Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CIN-102 Tablets Dose 1 | Experimental | Drug: CIN-102 Dose 1CIN-102 tablets by mouth twice daily for 14 days |
| Placebo for CIN-102 Dose 1 | Placebo comparator | Drug: Placebo for CIN-102Placebo tablets by mouth twice daily for 14 days |
| CIN-102 Dose 2 | Experimental | Drug: CIN-102 Dose 2CIN-102 tablets by mouth twice daily for 14 days |
| Placebo for CIN-102 Dose 2 | Placebo comparator | Drug: Placebo for CIN-102Placebo tablets by mouth twice daily for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIN-102 Dose 1Deuterated domperidone (deudomperidone) | Drug | CIN-102 Tablets Dose 1 |
| CIN-102 Dose 2Deuterated domperidone (deudomperidone) | Drug | CIN-102 Dose 2 |
| Placebo for CIN-102Placebo | Drug | Placebo for CIN-102 Dose 1, Placebo for CIN-102 Dose 2 |
Primary outcome
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
7 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Active, not recruiting
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Diabetes Mellitus, Gastroparesis With Diabetes Mellitus
Recruiting
Washed Microbiota Transplantation for Diabetic Gastroparesis
Diabetic Gastroparesis
Recruiting
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Murphy, MD, MPH study director
CinRx Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CIN-102 Dose 1 and CIN-102 Dose 2 in people with Diabetic Gastroparesis, run by CinDome Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.