TerminatedPhase 2

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

Stopped: Terminated based on Sponsor decision due to lot recall of GEBT kits impacting the primary endpoint evaluation for Dose 2 and Dose 3.

United States72 participantsStarted 2019-09-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

Timeframe: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

Timeframe: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

Trial details

NCT IDNCT04026997

SponsorCinDome Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-17

Results submitted2023-07-12

View on ClinicalTrials.gov More Gastroparesis trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

Timeframe: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14

The Percent Change From Baseline in Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-Time (T1/2)

Timeframe: Baseline (gathered between Days -10 to -3, prior to first dose of study drug) to Day 14