Status:
COMPLETED
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Lead Sponsor:
CinDome Pharma, Inc.
Conditions:
Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04026997
Start Date
September 11 2019
End Date
December 17 2020
Last Update
July 21 2021
Active Locations (19)
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1
Research Site 101
Chula Vista, California, United States, 91910
2
Research Site 114
Jacksonville, Florida, United States, 32224
3
Research Site 117
Miami, Florida, United States, 33134
4
Research Site 118
Miami, Florida, United States, 33183