A Phase 2 interventional study of Ondansetron 8mg and Placebo in Indigestion and Diabetes Mellitus, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 150 is above the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.
Drug: Ondansetron 8mg
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
Drug: Ondansetron 8mg
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
Drug: Ondansetron 8mg
Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.
Drug: 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
Drug: 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
Drug: Placebo
Oral Ondansetron 8 mg
Also known as: Zofran
Oral matched placebo
Change in severity of symptoms during enteral infusion
Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable
Time frame: baseline, every 15 minutes up to 8 hours
Change in severity of symptoms during gastric emptying study
Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable
Time frame: baseline, every 15 minutes up to 2 hours
Change in severity of daily symptoms
Gastroparesis Cardinal Symptom Index - Daily Diary (GCSI-DD) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe
Time frame: Baseline, daily for six weeks
Change in severity of gastrointestinal symptoms
Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe
Time frame: Baseline, 2 weeks, 6 weeks
Change in severity of gastrointestinal symptoms effect on Quality of Life
Gastrointestinal Disorders - Quality of Life and Well-Being (PAGI-QOL) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe
Time frame: Baseline, 2 weeks, 6 weeks
Change in effect of Gastrointestinal symptoms on Quality of Life
Nepean Dyspepsia Index used to measure symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe
Time frame: Baseline
Glucose level
Compare the changes in glucose level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Insulin level
Compare the changes in insulin level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
C-peptide level
Compare the changes in C-peptide level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Glucagon-like Peptide 1 (GLP-1)
Compare the changes in Glucagon-like Peptide 1 (GLP-1) level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Cholecystokinin (CCK)
Compare the changes in Cholecystokinin (CCK) level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Ghrelin
Compare the changes in Ghrelin level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Peptide YY (PYY)
Compare the change in Peptide YY (PYY) level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Plasma
Compare the change in plasma level during a lipid infusion
Time frame: baseline, approximately 60-120 minutes
Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index
Score is derived from 25 items pertaining to QOL
Time frame: Baseline
Severity of gastrointestinal symptoms - Nepean Dyspepsia index
Nepean Dyspepsia Index is used to measure symptom severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe
Time frame: Baseline
Plan to share: No
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Studies of the drug tested here: Ondansetron