A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Idiopathic Gastroparesis.
Completed · Phase 2 · Has a placebo group
Conditions studied: Idiopathic Gastroparesis
In brief
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
Key facts
- Study ID
- NCT06899217
- Run by
- CinDome Pharma, Inc.
- People needed
- 416
- Starts
- 2025-01-29
- Expected to finish
- 2026-05-07
- Last updated by the study team
- 2026-07-13
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
- The Center for Clinical Trials — Saraland, Alabama, United States
- Del Sol Research Management, LLC — Tucson, Arizona, United States
- Applied Research Center of Arkansas, Inc — Little Rock, Arkansas, United States
- Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
- Hope Clinical Research LLC — Canoga Park, California, United States
- Erick H. Alayo Medical Corporation — Chula Vista, California, United States
- Flourish Research - Los Angeles (Covina) — Covina, California, United States
- Gastro Care Institute — Lancaster, California, United States
- Downtown L.A. Research Center, Inc. — Los Angeles, California, United States
- Acclaim Clinical Research — San Diego, California, United States
- Focus Clinical Research - West Hills — West Hills, California, United States
- University of Colorado Anschutz — Aurora, Colorado, United States
- Rocky Mountain Gastroenterology (RMG) — Lakewood, Colorado, United States
- Paradigm Research - Wheatridge — Wheat Ridge, Colorado, United States
- Connecticut Clinical Research Institute, LLC — Bristol, Connecticut, United States
- American Family Research Group — Cape Coral, Florida, United States
- USA and International Research Inc. — Doral, Florida, United States
- Unique Clinical Trials — Doral, Florida, United States
- Advanced Medical Research Group — Hollywood, Florida, United States
- Nature Coast Clinical Research — Inverness, Florida, United States
- ENCORE Borland Groover Clinical Research — Jacksonville, Florida, United States
- Allied Biomedical Research Institute, Inc. — Miami, Florida, United States
- Advanced Research Institute Inc — New Port Richey, Florida, United States
- Gastro Health - Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.