Recruiting
Phase 2

Ondansetron

Sponsor:

Mayo Clinic

Code:

NCT03865290

Conditions

Indigestion

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ondansetron 8mg

Placebo

Study Details

Brief 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.

Conditions

Indigestion

Diabetes Mellitus

Study ID

NCT03865290

Start date

Apr 2, 2019

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy male or non-pregnant, non-breastfeeding female volunteers;
  • 18-75 years old;
  • Able to provide written informed consent before participating in the study
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study; including the willingness and ability to consume the components of the test meals
  • Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
  • Patients in the DM group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed

Exclusion Criteria:

  • Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are permissible)
  • Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
  • Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high doses of anticholinergic agents (eg, amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments.
  • Treatment with GLP-1 agonists and amlyin which cause vagal blockade and may affect central processing of pain
  • Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies
  • Positive tissue transglutaminase antibodies (TTG),
  • Pregnant or breast-feeding females
  • Known intolerance or allergy to eggs
  • Poor peripheral venous access, if central venous access is not available
  • Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
  • History of Long QT Syndrome or prolonged QT interval (i.e., corrected QT interval > 480 ms)
  • Current symptoms of a functional gastrointestinal disorder assessed by questionnaire
  • Severe vomiting that would preclude tube placement or participation in the study
  • Structural cause for symptoms by endoscopy within the past 12 months
  • Patients with gastric pacemakers

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ondansetron 8mg

Oral Ondansetron 8 mg

Placebo

Oral matched placebo

Primary outcome measure

  • Change in severity of symptoms during enteral infusion [ Time Frame: baseline, every 15 minutes up to 8 hours ]
  • Change in severity of symptoms during gastric emptying study [ Time Frame: baseline, every 15 minutes up to 2 hours ]
  • Change in severity of daily symptoms [ Time Frame: Baseline, daily for six weeks ]
  • Change in severity of gastrointestinal symptoms [ Time Frame: Baseline, 2 weeks, 6 weeks ]
  • Change in severity of gastrointestinal symptoms effect on Quality of Life [ Time Frame: Baseline, 2 weeks, 6 weeks ]
  • Change in effect of Gastrointestinal symptoms on Quality of Life [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Kelly J Feuerhak

507-255-6802Feuerhak.Kelly@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Kelly J Feuerhak

507-255-6802Feuerhak.Kelly@mayo.edu

Principal Investigator:

Adil E Bharucha, MD

More Information

Sponsor

Mayo Clinic

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-04.