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CIN-102 in Idiopathic Gastroparesis
NCT06899217Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2025
- Primary completion
- May 2026
- Countries
- 1
- Sponsor
- CinDome Pharma
- Modality
- Small Molecules
- Drugs
- deudomperidone
- Conditions
- idiopathic gastroparesis (IG)
01
Overview
Phase 2, randomised, double-blind trial of deudomperidone in idiopathic gastroparesis (IG) (3 arms), sponsored by CinDome Pharma. Primary endpoint: American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary Nausea Subscale Score at 12 weeks. Started Jan 2025; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
CIN-102: 15mg
15 mg CIN-102, taken orally BID for 12 weeks
CIN-102: 10mg
10 mg CIN-102, taken orally BID for 12 weeks
Placebo
Placebo for CIN-102, taken orally BID for 12 weeks
03
Who it enrols
Adults with idiopathic gastroparesis and documented delayed gastric emptying, excluding those with known primary causes of gastroparesis (e.g., diabetes, surgery) or recent hospitalization for the condition.
04
Endpoints
Primary
American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary Nausea Subscale Score
Secondary
Severity of gastroparesis-related symptoms
Percentage of subjects identified as responders with >=1 point reduction
Percentage of subjects identified as responders with >=0.5 point reduction
Percentage of subjects identified as responders with >=30% reduction
Percentage of symptom-free days
Percentage of symptomatic weeks
Patient Global Impression of Change
Patient Global Impression of Severity
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