A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetic Gastroparesis
In brief
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
Key facts
- Study ID
- NCT05832151
- Run by
- CinDome Pharma, Inc.
- People needed
- 382
- Starts
- 2023-03-27
- Expected to finish
- 2025-12-12
- Last updated by the study team
- 2025-12-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- G & L Research, LLC — Foley, Alabama, United States
- Clinical Research Associates, LLC — Huntsville, Alabama, United States
- Phoenix Medical Research Institute, LLC — Peoria, Arizona, United States
- Onyx Clinical Research — Phoenix, Arizona, United States
- Del Sol Research Management, LLC — Tucson, Arizona, United States
- Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
- Applied Research Center of Arkansas — Little Rock, Arkansas, United States
- Arkansas Gastroenterology - North Little Rock — North Little Rock, Arkansas, United States
- Alliance Research Institute - Bell Gardens — Bell Gardens, California, United States
- Hope Clinical Research LLC — Canoga Park, California, United States
- Alliance Research Institute, LLC — Canoga Park, California, United States
- Erick H. Alayo Medical Corporation — Chula Vista, California, United States
- GW Research Inc. — Chula Vista, California, United States
- Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
- New Hope Research Development — Corona, California, United States
- Aurora Care Clinic — Costa Mesa, California, United States
- Paragon Rx Clinical — Garden Grove, California, United States
- Valley View Wellness and Medical Center - VVCRD — Garden Grove, California, United States
- Torrance Clinical Research Institute Inc. — Lomita, California, United States
- Angel City Research — Los Angeles, California, United States
- Facey Medical Research — Mission Hills, California, United States
- Millennium Clinical Trials — Thousand Oaks, California, United States
- Innovative Research of West Florida — Clearwater, Florida, United States
- USA and International Research Inc. — Doral, Florida, United States
- Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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