A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

Gastroparesis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026997
• Other study ID #: CIN-102-121
• Status: Completed
• Phase: Phase 2
• Start date: September 11, 2019
• Est. completion date: December 17, 2020

Study information

• Verified date: July 2021
• Source: CinDome Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Research Site 111	Atlanta	Georgia
United States	Research Site 102	Boston	Massachusetts
United States	Research Site 101	Chula Vista	California
United States	Research Site 109	Great Neck	New York
United States	Research Site 107	Jackson	Tennessee
United States	Research Site 114	Jacksonville	Florida
United States	Research Site 110	Kansas City	Kansas
United States	Research Site 113	Las Vegas	Nevada
United States	Research Site 103	Louisville	Kentucky
United States	Research Site 112	Marrero	Louisiana
United States	Research Site 117	Miami	Florida
United States	Research Site 118	Miami	Florida
United States	Research Site 104	Monroe	Louisiana
United States	Research Site 121	Omaha	Nebraska
United States	Research Site 106	Philadelphia	Pennsylvania
United States	Research Site 115	Rapid City	South Dakota
United States	Research Site 119	Summerville	South Carolina
United States	Research Site 105	Tulsa	Oklahoma
United States	Research Site 120	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CinDome Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in gastric emptying		Baseline (gathered on Days -10 to -3) to Day 14
Secondary	Change from baseline in gastric emptying terminal phase elimination half life		Baseline (gathered on Days -10 to -3) to Day 14
Secondary	The change from baseline in ANMS GCSI-DD total scores		Day -14 to 14
Secondary	The change from baseline in ANMS GCSI-DD subscale scores		Day -14 to 14