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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: Completed Phase 2 study of Diabetic Gastroparesis, sponsored by CinDome Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale scores and the Vomiting 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 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
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2025-12-12 |
| Phase | Phase 2 |
What the finished NCT05832151 record still lists
NCT05832151 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 7 other Diabetic Gastroparesis trials with a reported enrollment target (257% higher).
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 names 20 study sites across 4 states, led by 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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