A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
NCT ID: NCT04026997
Last Updated: 2021-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2019-09-11
2020-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 1
CIN-102 Dose 1
Cohort 1 - Placebo
Placebo tablets by mouth twice daily for 14 days
Placebo
Placebo
Cohort 2
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 2
CIN-102 Dose 2
Cohort 2- Placebo
Placebo tablets by mouth twice daily for 14 days
Placebo
Placebo
Cohort 3
CIN-102 tablets by mouth twice daily for 14 days
CIN-102 Dose 3
CIN-102 Dose 3
Cohort 3- Placebo
Placebo tablets by mouth twice daily for 14 days
Placebo
Placebo
Interventions
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CIN-102 Dose 1
CIN-102 Dose 1
CIN-102 Dose 2
CIN-102 Dose 2
CIN-102 Dose 3
CIN-102 Dose 3
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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CinDome Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site 101
Chula Vista, California, United States
Research Site 114
Jacksonville, Florida, United States
Research Site 117
Miami, Florida, United States
Research Site 118
Miami, Florida, United States
Research Site 111
Atlanta, Georgia, United States
Research Site 110
Kansas City, Kansas, United States
Research Site 103
Louisville, Kentucky, United States
Research Site 112
Marrero, Louisiana, United States
Research Site 104
Monroe, Louisiana, United States
Research Site 102
Boston, Massachusetts, United States
Research Site 121
Omaha, Nebraska, United States
Research Site 113
Las Vegas, Nevada, United States
Research Site 109
Great Neck, New York, United States
Research Site 120
Winston-Salem, North Carolina, United States
Research Site 105
Tulsa, Oklahoma, United States
Research Site 106
Philadelphia, Pennsylvania, United States
Research Site 119
Summerville, South Carolina, United States
Research Site 115
Rapid City, South Dakota, United States
Research Site 107
Jackson, Tennessee, United States
Countries
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Other Identifiers
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CIN-102-121
Identifier Type: -
Identifier Source: org_study_id
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