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Trial record 1 of 1 for:    cindome | Recruiting, Not yet recruiting Studies | gastroparesis
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A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

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ClinicalTrials.gov Identifier: NCT04026997
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
CinDome Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE September 11, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
Change from baseline in gastric emptying [ Time Frame: Baseline (gathered on Days -10 to -3) to Day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
Change from baseline in gastric emptying [ Time Frame: Baseline (gathered on Days -7 to -2) to Day 14 ]
The GEBT is a nonradioactive stable isotope breath test, in which the ratio of exhaled 13CO2/12CO2 is used to determine the rate of gastric emptying after consumption of a standardized, 13C-enriched meal. Patients will consume a standardized, 13C-enriched meal after a 6-hour fast at baseline (Days -7 to -2) and after a 6-hour fast starting 30 minutes after study drug administration on Day 14 (±2 days). Breath samples will be obtained twice prior to consumption of a standardized, 13C-enriched meal and then at 45, 90, 120, 150, 180, and 240 minutes after meal consumption after a 6-hour fast on Days -7 to -2 and Day 14 (±2 days) and 30 minutes after study drug administration on Day 14 (±2 days).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
  • Change from baseline in gastric emptying terminal phase elimination half life [ Time Frame: Baseline (gathered on Days -10 to -3) to Day 14 ]
  • The change from baseline in ANMS GCSI-DD total scores [ Time Frame: Day -14 to 14 ]
  • The change from baseline in ANMS GCSI-DD subscale scores [ Time Frame: Day -14 to 14 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • Change from baseline in gastric emptying terminal phase elimination half life [ Time Frame: Baseline (gathered on Days -7 to -2) to Day 14 ]
    The GEBT is a nonradioactive stable isotope breath test, in which the ratio of exhaled 13CO2/12CO2 is used to determine the rate of gastric emptying after consumption of a standardized, 13C-enriched meal. Patients will consume a standardized, 13C-enriched meal after a 6-hour fast at baseline (Days -7 to -2) and after a 6-hour fast starting 30 minutes after study drug administration on Day 14 (±2 days). Breath samples will be obtained twice prior to consumption of a standardized, 13C-enriched meal and then at 45, 90, 120, 150, 180, and 240 minutes after meal consumption after a 6-hour fast on Days -7 to -2 and Day 14 (±2 days) and 30 minutes after study drug administration on Day 14 (±2 days).
  • The change from baseline in ANMS GCSI-DD total scores [ Time Frame: Day -14 to 14 ]
    The ANMS GCSI-DD covers 5 core relevant symptoms of gastroparesis: nausea, early satiety, postprandial fullness, upper abdominal pain and vomiting. Bloating is included as an exploratory symptom. Symptoms are rated on a severity numeric response scale from 0 (none) to 4 (very severe). Vomiting is captured on a frequency response scale and scored as follows: 0 for no episodes, 1 for one episode, 1 for 2 episodes, 3 for 3 episodes, and 4 for 4 or more episodes. Patients will be asked to recall symptoms over the previous 24 hours and complete the ANMS GCSI-DD patient-reported symptom questionnaire for at least 14 days prior to randomization, on the day of randomization, and daily from Days 1 to 14 (±2 days).
  • The change from baseline in ANMS GCSI-DD subscale scores [ Time Frame: Day -14 to 14 ]
    The ANMS GCSI-DD covers 5 core relevant symptoms of gastroparesis: nausea, early satiety, postprandial fullness, upper abdominal pain and vomiting. Bloating is included as an exploratory symptom. Symptoms are rated on a severity numeric response scale from 0 (none) to 4 (very severe). Vomiting is captured on a frequency response scale and scored as follows: 0 for no episodes, 1 for one episode, 1 for 2 episodes, 3 for 3 episodes, and 4 for 4 or more episodes. Patients will be asked to recall symptoms over the previous 24 hours and complete the ANMS GCSI-DD patient-reported symptom questionnaire for at least 14 days prior to randomization, on the day of randomization, and daily from Days 1 to 14 (±2 days).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Brief Summary This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastroparesis
Intervention  ICMJE
  • Drug: CIN-102 Dose 1
    CIN-102 Dose 1
  • Drug: CIN-102 Dose 2
    CIN-102 Dose 2
  • Drug: CIN-102 Dose 3
    CIN-102 Dose 3
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    CIN-102 tablets by mouth twice daily for 14 days
    Intervention: Drug: CIN-102 Dose 1
  • Placebo Comparator: Cohort 1 - Placebo
    Placebo tablets by mouth twice daily for 14 days
    Intervention: Drug: Placebo
  • Experimental: Cohort 2
    CIN-102 tablets by mouth twice daily for 14 days
    Intervention: Drug: CIN-102 Dose 2
  • Placebo Comparator: Cohort 2- Placebo
    Placebo tablets by mouth twice daily for 14 days
    Intervention: Drug: Placebo
  • Experimental: Cohort 3
    CIN-102 tablets by mouth twice daily for 14 days
    Intervention: Drug: CIN-102 Dose 3
  • Active Comparator: Cohort 3- Placebo
    Placebo tablets by mouth twice daily for 14 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients 18 to 70 years old.
  • Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.
  • Presence of moderate to severe nausea.
  • Body mass index (BMI) between 18 and 40 kg/m2, inclusive.
  • Glycosylated hemoglobin level <11% at Screening.
  • Willing to washout from ongoing treatment for gastroparesis.
  • Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

  • Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.
  • Positive test for drugs of abuse at the screening or evaluation visits.
  • Personal or family history of prolonged heart rate-corrected QT.
  • History or evidence of clinically significant arrhythmia.
  • History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.
  • Females who are pregnant, nursing, or planning on becoming pregnant during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brendan Doran, PharmD +1-844-531-1834 bdoran@cinrx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026997
Other Study ID Numbers  ICMJE CIN-102-121
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CinDome Pharma, Inc.
Study Sponsor  ICMJE CinDome Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CinDome Pharma, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP