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NCT06899217 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
A Phase 2 study of Idiopathic Gastroparesis, sponsored by CinDome Pharma.
- Active
- Registry status
- Phase 2
- Development phase
- 416
- Enrollment target
- 20
- Study locations
NCT06899217: Active Phase 2 study of Idiopathic Gastroparesis, sponsored by CinDome Pharma.
NCT06899217 is a Phase 2 study of Idiopathic Gastroparesis that is active but no longer recruiting, run by CinDome Pharma. The registered enrollment target is 416 participants, above the 126-participant average among 4 other Idiopathic Gastroparesis trials with a reported enrollment target (230% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06899217, a Phase 2 study of Idiopathic Gastroparesis, is active but no longer recruiting, sponsored by CinDome Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 416 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 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
Primary Outcome
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale Scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CIN-102 Dose 15mg
- DRUG CIN-102 Dose 10mg
Study Locations (20)
California
- Hope Clinical Research LLC - Canoga Park
- Erick H. Alayo Medical Corporation - Chula Vista
- Flourish Research - Los Angeles (Covina) - Covina
- Gastro Care Institute - Lancaster
- Downtown L.A. Research Center, Inc. - Los Angeles
- Acclaim Clinical Research - San Diego
- Focus Clinical Research - West Hills - West Hills
Alabama
- Gastro Health - Birmingham - Birmingham
- G & L Research, LLC - Foley
- The Center for Clinical Trials - Saraland
Colorado
- University of Colorado Anschutz - Aurora
- Rocky Mountain Gastroenterology (RMG) - Lakewood
- Paradigm Research - Wheatridge - Wheat Ridge
Florida
- American Family Research Group - Cape Coral
- USA and International Research Inc. - Doral
- Unique Clinical Trials - Doral
Arkansas
- Applied Research Center of Arkansas, Inc - Little Rock
- Preferred Research Partners, Inc. - Little Rock
Arizona
- Del Sol Research Management, LLC - Tucson
Connecticut
- Connecticut Clinical Research Institute, LLC - Bristol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2025-01-29 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 2 |
What the registry record for NCT06899217 still lists
NCT06899217 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 4 other Idiopathic Gastroparesis trials with a reported enrollment target (230% higher).
The record links to 1 condition, with Idiopathic Gastroparesis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06899217 names 20 study sites across 7 states, led by California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT06899217 about?
NCT06899217 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.". 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 gastrop...
What is the current status of trial NCT06899217?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 416 participants. The study started on 2025-01-29. Estimated completion is 2026-05-01.
What conditions does trial NCT06899217 study?
This clinical trial studies the following conditions: Idiopathic Gastroparesis.
What interventions are being tested in trial NCT06899217?
The interventions under investigation include: Placebo (DRUG), CIN-102 Dose 15mg (DRUG), CIN-102 Dose 10mg (DRUG).
Who is sponsoring clinical trial NCT06899217?
This trial is sponsored by CinDome Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06899217 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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