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Trial record 2 of 2 for:    cindome
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A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04026997
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
CinDome Pharma, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: CIN-102 Dose 1 Drug: CIN-102 Dose 2 Drug: CIN-102 Dose 3 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
CIN-102 tablets by mouth twice daily for 14 days
 Drug: CIN-102 Dose 1
CIN-102 Dose 1
Placebo Comparator: Cohort 1 - Placebo
Placebo tablets by mouth twice daily for 14 days
 Drug: Placebo
Placebo
Experimental: Cohort 2
CIN-102 tablets by mouth twice daily for 14 days
 Drug: CIN-102 Dose 2
CIN-102 Dose 2
Placebo Comparator: Cohort 2- Placebo
Placebo tablets by mouth twice daily for 14 days
 Drug: Placebo
Placebo
Experimental: Cohort 3
CIN-102 tablets by mouth twice daily for 14 days
 Drug: CIN-102 Dose 3
CIN-102 Dose 3
Active Comparator: Cohort 3- Placebo
Placebo tablets by mouth twice daily for 14 days
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in gastric emptying [ Time Frame: Baseline (gathered on Days -10 to -3) to Day 14 ]

Secondary Outcome Measures :
  1. Change from baseline in gastric emptying terminal phase elimination half life [ Time Frame: Baseline (gathered on Days -10 to -3) to Day 14 ]
  2. The change from baseline in ANMS GCSI-DD total scores [ Time Frame: Day -14 to 14 ]
  3. The change from baseline in ANMS GCSI-DD subscale scores [ Time Frame: Day -14 to 14 ]

Eligibility Criteria
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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.
  • 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.
Contacts and Locations
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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): NCT04026997


Contacts
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Contact: Brendan Doran, PharmD +1-844-531-1834 bdoran@cinrx.com

Locations
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United States, California
Research site Recruiting
Chula Vista, California, United States, 91910
United States, Florida
Research Site Recruiting
Miami, Florida, United States, 33134
Research Site Recruiting
Miami, Florida, United States, 33183
United States, Georgia
Research Site Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Kansas
Research Site Not yet recruiting
Kansas City, Kansas, United States, 66045
United States, Kentucky
Research Site Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Research Site Recruiting
Marrero, Louisiana, United States, 70072
Research site Recruiting
Monroe, Louisiana, United States, 71201
United States, Massachusetts
Research Site Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Nebraska
Research Site Not yet recruiting
Omaha, Nebraska, United States, 68134
United States, Nevada
Research site Recruiting
Las Vegas, Nevada, United States, 89123
United States, New York
Research site Recruiting
Great Neck, New York, United States, 11023
United States, North Carolina
Research Site Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Research site Recruiting
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Research Site Not yet recruiting
Summerville, South Carolina, United States, 29485
United States, South Dakota
Research Site Recruiting
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Research site Recruiting
Jackson, Tennessee, United States, 38305
Sponsors and Collaborators
CinDome Pharma, Inc.
More Information
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Responsible Party: CinDome Pharma, Inc.
ClinicalTrials.gov Identifier: NCT04026997    
Other Study ID Numbers: CIN-102-121
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 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
Signs and Symptoms