Ondansetron 8mg for Diabetes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetes+1 MoreOndansetron 8mg - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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: Drug
Non-ulcer dyspepsia (NUD) Ondansetron 8 mg
Drug
Experimental Group · 1 Intervention: Ondansetron 8mg · Intervention Types: Drug
Diabetic (DM) gastroenteropathy Ondansetron 8 mg
Drug
Experimental Group · 1 Intervention: Ondansetron 8mg · Intervention Types: Drug
Non-ulcer dyspepsia (NUD) Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Diabetic (DM) gastroenteropathy Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Healthy Control Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
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.