NCT03865290

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Researchers are trying to understand why people with indigestion and diabetes mellitus have gastrointestinal symptoms and in particular to understand whether symptoms are related to increased sensitivity to nutrients in the small intestine. As part of this investigation, a medication called ondansetron will also be studied to determine its effects on gastrointestinal function and associated symptoms.

Detailed description

The primary objectives of this study are to evaluate the effects of ondansetron, on symptoms (i) during a gastric emptying study, (ii) during enteral lipid infusion and (iii) in daily life.

Conditions

• Indigestion
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ondansetron 8mg	Oral Ondansetron 8 mg
DRUG	Placebo	Oral matched placebo

Timeline

• Start date: 2019-04-02
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2019-03-06
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study