IndigestionPhase 2NCT03865290
Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
A Phase 2 study testing Ondansetron 8mg in people with Indigestion and Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Indigestion, Diabetes Mellitus
- What is being tested?
- Ondansetron 8mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Kelly J Feuerhak, 507-255-6802, Feuerhak.Kelly@mayo.edu
Adil E Bharucha, MD
About this study
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.
Read the 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
- Being tested
- Ondansetron 8mg, Placebo
- Medical subject headings
- Dyspepsia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
Also called Zofran
Oral Ondansetron 8 mg
PlaceboDrug
Oral matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Ondansetron 8 mg | Experimental | Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. Receives: Drug: Ondansetron 8mg |
| Diabetic (DM) gastroenteropathy Ondansetron 8 mg | Experimental | 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 Receives: Drug: Ondansetron 8mg |
| Non-ulcer dyspepsia (NUD) Ondansetron 8 mg | Experimental | 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 Receives: Drug: Ondansetron 8mg |
| Healthy Control Placebo | Placebo comparator | Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. Receives: Drug: Placebo |
| Diabetic (DM) gastroenteropathy Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
| Non-ulcer dyspepsia (NUD) Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Secondary outcomes (10)
Glucose level
Compare the changes in glucose level during a lipid infusion
Measured: baseline, approximately 60-120 minutes
Insulin level
Compare the changes in insulin level during a lipid infusion
Measured: baseline, approximately 60-120 minutes
C-peptide level
Compare the changes in C-peptide level during a lipid infusion
Measured: 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
Measured: baseline, approximately 60-120 minutes
Cholecystokinin (CCK)
Compare the changes in Cholecystokinin (CCK) level during a lipid infusion
Measured: baseline, approximately 60-120 minutes
Ghrelin
Compare the changes in Ghrelin level during a lipid infusion
Measured: baseline, approximately 60-120 minutes
Peptide YY (PYY)
Compare the change in Peptide YY (PYY) level during a lipid infusion
Measured: baseline, approximately 60-120 minutes
Plasma
Compare the change in plasma level during a lipid infusion
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start2 Apr 2019
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndigestionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adil Bharucha, MBBS, MD, Mayo Clinic
- Investigators
- Adil E Bharucha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865290
- Sponsor's protocol ID
- 18-005041
- Other IDs
- P01DK068055
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
- ClinicalTrials.gov ID
- NCT03865290
- Acronym / sponsor ID
- 18-005041
- Conditions
- Indigestion, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Ondansetron 8 mg | Experimental | Drug: Ondansetron 8mgOral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion. |
| Diabetic (DM) gastroenteropathy Ondansetron 8 mg | Experimental | Drug: Ondansetron 8mgOral 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 |
| Non-ulcer dyspepsia (NUD) Ondansetron 8 mg | Experimental | Drug: Ondansetron 8mgOral 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 |
| Healthy Control Placebo | Placebo comparator | Drug: PlaceboOral matched placebo administered in a single does dose during gastric emptying and duodenal infusion. |
| Diabetic (DM) gastroenteropathy Placebo | Placebo comparator | Drug: PlaceboOral 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 |
| Non-ulcer dyspepsia (NUD) Placebo | Placebo comparator | Drug: PlaceboOral 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 8mgAlso: ZofranOral Ondansetron 8 mg | Drug | Diabetic (DM) gastroenteropathy Ondansetron 8 mg, Healthy Control Ondansetron 8 mg, Non-ulcer dyspepsia (NUD) Ondansetron 8 mg |
| PlaceboOral matched placebo | Drug | Diabetic (DM) gastroenteropathy Placebo, Healthy Control Placebo, Non-ulcer dyspepsia (NUD) Placebo |
Primary outcome
Change in severity of symptoms during enteral infusion
Time frame: baseline, every 15 minutes up to 8 hours
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
Change in severity of symptoms during gastric emptying study
Time frame: baseline, every 15 minutes up to 2 hours
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
Change in severity of daily symptoms
Time frame: Baseline, daily for six weeks
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
Change in severity of gastrointestinal symptoms
Time frame: Baseline, 2 weeks, 6 weeks
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
Change in severity of gastrointestinal symptoms effect on Quality of Life
Time frame: Baseline, 2 weeks, 6 weeks
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
Change in effect of Gastrointestinal symptoms on Quality of Life
Time frame: Baseline
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
10 secondary outcomes
Glucose level
Time frame: baseline, approximately 60-120 minutes
Insulin level
Time frame: baseline, approximately 60-120 minutes
C-peptide level
Time frame: baseline, approximately 60-120 minutes
Glucagon-like Peptide 1 (GLP-1)
Time frame: baseline, approximately 60-120 minutes
Cholecystokinin (CCK)
Time frame: baseline, approximately 60-120 minutes
Ghrelin
Time frame: baseline, approximately 60-120 minutes
Peptide YY (PYY)
Time frame: baseline, approximately 60-120 minutes
Plasma
Time frame: baseline, approximately 60-120 minutes
Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index
Time frame: Baseline
Severity of gastrointestinal symptoms - Nepean Dyspepsia index
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adil E Bharucha, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ondansetron 8mg in people with Indigestion and Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly J Feuerhak (507-255-6802, Feuerhak.Kelly@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of symptoms during enteral infusion (time frame: baseline, every 15 minutes up to 8 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.