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A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.

NCT06899217 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-02-23

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help to decrease nausea severity associated with idiopathic gastroparesis severity in adult subjects.

The main questions it aims to answer are:

* To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with idiopathic gastroparesis compared to a placebo
* To evaluate the safety of CIN-102 when given to patients with idiopathic gastroparesis compared to a placebo

Participants will go through the following schedule:

* Pre-screening (1 visit)
* Screening \& Lead-In (1-2 visits)

* Will complete a Gastric Emptying Breath Test (GEBT)
* Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation.
* Lead-In Period (1 visit)
* 12-week treatment period (7 visits)

* Study drug taken twice daily by mouth
* Will complete daily diaries and other PROs as described in protocol
* 1 week follow-up (1 visit)

Researchers will compare the effects of the following treatments:

* 15 mg CIN-102, taken orally BID for 12 weeks
* 10 mg CIN-102, taken orally BID for 12 weeks
* Placebo for CIN-102, taken orally BID for 12 weeks

Conditions

  • Idiopathic Gastroparesis

Interventions

DRUG

CIN-102 Dose 15mg

Twice daily for 12 weeks

DRUG

Placebo

Twice daily for 12 weeks

DRUG

CIN-102 Dose 10mg

Twice daily for 12 weeks

Sponsors & Collaborators

  • CinDome Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2026-05-01
Completion
2026-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06899217 on ClinicalTrials.gov