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.
Eligible Conditions
- Diabetes
- Indigestion
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 10 Secondary · Reporting Duration: baseline, approximately 60-120 minutes
Baseline
Change in effect of Gastrointestinal symptoms on Quality of Life
Effect of gastrointestinal symptoms on Quality of Life - Nepean Dyspepsia index
Severity of gastrointestinal symptoms - Nepean Dyspepsia index
Week 6
Change in severity of gastrointestinal symptoms
Change in severity of gastrointestinal symptoms effect on Quality of Life
Baseline, daily for six weeks
Change in severity of daily symptoms
baseline, approximately 60-120 minutes
C-peptide level
Cholecystokinin (CCK)
Ghrelin
Glucagon-like Peptide 1 (GLP-1)
Glucose level
Insulin
Peptide YY (PYY)
Plasma
Hour 2
Change in severity of symptoms during gastric emptying study
Hour 8
Change in severity of symptoms during enteral infusion
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
6 Treatment Groups
Healthy Control Ondansetron 8 mg
1 of 6
Non-ulcer dyspepsia (NUD) Ondansetron 8 mg
1 of 6
Diabetic (DM) gastroenteropathy Ondansetron 8 mg
1 of 6
Non-ulcer dyspepsia (NUD) Placebo
1 of 6
Diabetic (DM) gastroenteropathy Placebo
1 of 6
Healthy Control Placebo
1 of 6
Experimental Treatment
Non-Treatment Group
150 Total Participants · 6 Treatment Groups
Primary Treatment: Ondansetron 8mg · Has Placebo Group · Phase 2
Healthy Control Ondansetron 8 mg
Drug
Experimental Group · 1 Intervention: Ondansetron 8mg · Intervention Types: DrugNon-ulcer dyspepsia (NUD) Ondansetron 8 mg
Drug
Experimental Group · 1 Intervention: Ondansetron 8mg · Intervention Types: DrugDiabetic (DM) gastroenteropathy Ondansetron 8 mg
Drug
Experimental Group · 1 Intervention: Ondansetron 8mg · Intervention Types: DrugNon-ulcer dyspepsia (NUD) Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugDiabetic (DM) gastroenteropathy Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugHealthy Control Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ondansetron
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, approximately 60-120 minutes
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,629 Total Patients Enrolled
104 Trials studying Diabetes
121,514 Patients Enrolled for Diabetes
Mayo ClinicLead Sponsor
2,922 Previous Clinical Trials
3,517,003 Total Patients Enrolled
20 Trials studying Diabetes
1,985 Patients Enrolled for Diabetes
Adil E Bharucha, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
160 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you: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.
You are able to communicate adequately with the investigator and to comply with the requirements for the entire study.
Symptoms of dyspepsia (i.e.
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Conditions
Cancer Related
Treatments