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NCT05832151 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis

A Phase 2 study of Diabetic Gastroparesis, sponsored by CinDome Pharma.

Completed
Registry status
Phase 2
Development phase
382
Enrollment target
20
Study locations

NCT05832151 is a Phase 2 study of Diabetic Gastroparesis that has completed, run by CinDome Pharma. The registered enrollment target is 382 participants, above the 107-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (257% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT05832151, a Phase 2 study of Diabetic Gastroparesis, has completed, sponsored by CinDome Pharma.

COMPLETED
Registry status
Phase 2
Development phase
382 participants
Enrollment target
20
Study locations

Study Summary

The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo * To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo Participants will go through the following schedule: * Screening period (1-2 visits) * Lead-in period (1 visit) * 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 * 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: * Drug- CIN-102 Dose 15 mg or 10 mg * Drug- Placebo

Conditions Studied

Diabetic Gastroparesis

Interventions

  • DRUG Placebo
  • DRUG CIN-102 Dose 15mg or 10mg

Study Locations (20)

California

  • Alliance Research Institute - Bell Gardens - Bell Gardens
  • Hope Clinical Research LLC - Canoga Park
  • Alliance Research Institute, LLC - Canoga Park
  • Erick H. Alayo Medical Corporation - Chula Vista
  • GW Research Inc. - Chula Vista
  • Kindred Medical Institute for Clinical Trials, LLC - Corona
  • New Hope Research Development - Corona
  • Aurora Care Clinic - Costa Mesa
  • Paragon Rx Clinical - Garden Grove
  • Valley View Wellness and Medical Center - VVCRD - Garden Grove
  • Torrance Clinical Research Institute Inc. - Lomita

Alabama

  • Digestive Health Specialists of the Southeast - Dothan
  • G & L Research, LLC - Foley
  • Clinical Research Associates, LLC - Huntsville

Arizona

  • Phoenix Medical Research Institute, LLC - Peoria
  • Onyx Clinical Research - Phoenix
  • Del Sol Research Management, LLC - Tucson

Arkansas

  • Preferred Research Partners, Inc. - Little Rock
  • Applied Research Center of Arkansas - Little Rock
  • Arkansas Gastroenterology - North Little Rock - North Little Rock

Trial Details

FieldValue
Enrollment Target 382 participants
Start Date 2023-03-27
Est. Completion 2025-12-12
Phase Phase 2

Sponsor

CinDome Pharma

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05832151

The ClinicalTrials.gov registry entry for NCT05832151 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (257% higher). The listed sponsor is CinDome Pharma, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05832151 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT05832151 about?

NCT05832151 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis". The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients. The main questions it aims to answer are: * To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given t...

What is the current status of trial NCT05832151?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 382 participants. The study started on 2023-03-27. Estimated completion is 2025-12-12.

What conditions does trial NCT05832151 study?

This clinical trial studies the following conditions: Diabetic Gastroparesis.

What interventions are being tested in trial NCT05832151?

The interventions under investigation include: Placebo (DRUG), CIN-102 Dose 15mg or 10mg (DRUG).

Who is sponsoring clinical trial NCT05832151?

This trial is sponsored by CinDome Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05832151 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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