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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03865290
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Indigestion

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Ondansetron 8mg — DRUG
    Oral Ondansetron 8 mg
  • Placebo — DRUG
    Oral matched placebo

Study Details

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.

Key Dates

Start date
Apr 2, 2019
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Healthy Control Ondansetron 8 mg
    Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.
  • Experimental: Diabetic (DM) gastroenteropathy Ondansetron 8 mg
    Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Oral Ondansetron 8 mg administered three times a day for weeks 3-6
  • Experimental: Non-ulcer dyspepsia (NUD) Ondansetron 8 mg
    Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Oral Ondansetron 8 mg administered three times a day for weeks 3-6
  • Placebo Comparator: Healthy Control Placebo
    Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.
  • Placebo Comparator: Diabetic (DM) gastroenteropathy Placebo
    Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Oral matched placebo administered three times a day for weeks 3-6
  • Placebo Comparator: Non-ulcer dyspepsia (NUD) Placebo
    Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Oral matched placebo administered three times a day for weeks 3-6

Primary Outcome Measure

Change in severity of symptoms during enteral infusion [ Time Frame: baseline, every 15 minutes up to 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Kelly J Feuerhak
[email protected]
507-255-6802
Adil E Bharucha, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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