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5-HT3 Receptor Antagonist

Ondansetron for Indigestion in Diabetics

Phase 2

Recruiting

Led By Adil E Bharucha, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Healthy male or non-pregnant, non-breastfeeding female volunteers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, approximately 60-120 minutes

Awards & highlights

Study Summary

This trial is investigating the link between gastrointestinal symptoms, indigestion, and diabetes mellitus. They will also study the effects of ondansetron on these symptoms.

Who is the study for?

This trial is for adults aged 18-75 with diabetes (Type 1 or Type 2) and indigestion symptoms that started or worsened after their diabetes diagnosis. Participants must be able to eat test meals and not be pregnant, breastfeeding, or have a structural cause for symptoms. Those with significant health issues, certain heart conditions, allergies to eggs, or on specific medications are excluded.Check my eligibility

What is being tested?

The study tests the effects of Ondansetron (8mg), an anti-nausea medication, against a placebo in managing gastrointestinal discomfort in people with both indigestion and diabetes. It aims to understand if this drug can reduce sensitivity to nutrients causing these symptoms.See study design

What are the potential side effects?

Ondansetron may cause headaches, constipation or diarrhea, dizziness and fatigue. Rarely it can lead to more serious side effects like changes in heartbeat rhythm. The experience of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had diabetes for over 3 years and my stomach discomfort started or got worse after my diagnosis.

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I am a healthy male or a female not pregnant or breastfeeding.

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I have symptoms like feeling full quickly, discomfort after eating, nausea, or vomiting.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in effect of Gastrointestinal symptoms on Quality of Life

Change in severity of daily symptoms

Change in severity of gastrointestinal symptoms

+3 more

Secondary outcome measures

C-peptide level

Cholecystokinin (CCK)

Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index

+7 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Non-ulcer dyspepsia (NUD) Ondansetron 8 mgExperimental Treatment1 Intervention

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

Group II: Healthy Control Ondansetron 8 mgExperimental Treatment1 Intervention

Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.

Group III: Diabetic (DM) gastroenteropathy Ondansetron 8 mgExperimental Treatment1 Intervention

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

Group IV: Diabetic (DM) gastroenteropathy PlaceboPlacebo Group1 Intervention

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

Group V: Healthy Control PlaceboPlacebo Group1 Intervention

Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.

Group VI: Non-ulcer dyspepsia (NUD) PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ondansetron 8mg

2022

Completed Phase 4

~450

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,767,007 Total Patients Enrolled

22 Trials studying Diabetes

6,803 Patients Enrolled for Diabetes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,345 Total Patients Enrolled

107 Trials studying Diabetes

138,663 Patients Enrolled for Diabetes

Adil E Bharucha, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

Ondansetron (5-HT3 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03865290 — Phase 2

Diabetes Research Study Groups: Diabetic (DM) gastroenteropathy Placebo, Healthy Control Placebo, Non-ulcer dyspepsia (NUD) Placebo, Healthy Control Ondansetron 8 mg, Non-ulcer dyspepsia (NUD) Ondansetron 8 mg, Diabetic (DM) gastroenteropathy Ondansetron 8 mg

Diabetes Clinical Trial 2023: Ondansetron Highlights & Side Effects. Trial Name: NCT03865290 — Phase 2

Ondansetron (5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03865290 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements to partake in this research?

"In this medical trial, 150 adults aged 18 and 75 with a diagnosis of diabetes mellitus are being recruited. Patients must meet certain criteria such as possessing type 1 or 2 DM for at least three years; not pregnant, breastfeeding or male; capable of providing informed consent before participating in the study and having dyspeptic symptoms."

Answered by AI

Is participation in this research limited to those over twenty years of age?

"This clinical trial is open to individuals 18 years of age or older, with a maximum enrolment cap of 75."

Answered by AI

What is the participant capacity for this medical research?

"Affirmative, clinicaltrials.gov reveals that this medical experiment is actively engaging patients since it was first posted on April 2nd 2019 and updated most recently on May 18th 2021. 150 individuals must be enrolled from one location."

Answered by AI

Is this investigation taking on new participants?

"According to clinicaltrials.gov, this medical study is actively enrolling participants. Its initial posting was on April 2nd 2019 and its data has been updated most recently on May 18th 2022."

Answered by AI

What is the main purpose of this trial?

"The primary metric evaluated over a Baseline, 2 weeks and 6 week period of this trial is the Change in severity of gastrointestinal symptoms. Secondary outcomes include Effect on Quality of Life as measured by Nepean Dyspepsia Index (0=none to 5=very severe), C-Peptide Level during lipid infusion comparison, and Severity assessed using Nepean Dypespia Index."

Answered by AI

For what clinical purpose is Ondansetron 8mg typically prescribed?

"Ondansetron 8mg is commonly administered to those suffering from uremia, but the medication has also been known to successfully treat other conditions such as radiation therapy induced nausea and vomiting, pharmacotherapy-related symptoms, and pruritus."

Answered by AI