Clinical trial NCT04026997: A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroparesis
Lead sponsor: CinDome Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in gastric emptying
timeFrame: Baseline (gathered on Days -10 to -3) to Day 14
Secondary outcomes:
measure: Change from baseline in gastric emptying terminal phase elimination half life
timeFrame: Baseline (gathered on Days -10 to -3) to Day 14
measure: The change from baseline in ANMS GCSI-DD total scores
timeFrame: Day -14 to 14
measure: The change from baseline in ANMS GCSI-DD subscale scores
timeFrame: Day -14 to 14
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site 101
state: California
city: Jacksonville
country: United States
facility: Research Site 114
state: Florida
city: Miami
country: United States
facility: Research Site 117
state: Florida
city: Miami
country: United States
facility: Research Site 118
state: Florida
city: Atlanta
country: United States
facility: Research Site 111
state: Georgia
city: Kansas City
country: United States
facility: Research Site 110
state: Kansas
city: Louisville
country: United States
facility: Research Site 103
state: Kentucky
city: Marrero
country: United States
facility: Research Site 112
state: Louisiana
city: Monroe
country: United States
facility: Research Site 104
state: Louisiana
city: Boston
country: United States
facility: Research Site 102
state: Massachusetts
city: Omaha
country: United States
facility: Research Site 121
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site 113
state: Nevada
city: Great Neck
country: United States
facility: Research Site 109
state: New York
city: Winston-Salem
country: United States
facility: Research Site 120
state: North Carolina
city: Tulsa
country: United States
facility: Research Site 105
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site 106
state: Pennsylvania
city: Summerville
country: United States
facility: Research Site 119
state: South Carolina
city: Rapid City
country: United States
facility: Research Site 115
state: South Dakota
city: Jackson
country: United States
facility: Research Site 107
state: Tennessee
Study officials:
References: