Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Who is this study for? Patients with diabetes mellitus and dyspepsia
What treatments are being studied? Ondansetron
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. As part of this investigation, a medication called ondansetron will also be studied to determine its effects on gastrointestinal function and associated symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Kelly J Feuerhak
Feuerhak.Kelly@mayo.edu
507-255-6802
Time Frame
Start Date: 2019-04-02
Estimated Completion Date: 2028-03
Participants
Target number of participants: 150
Treatments
Experimental: Healthy Control Ondansetron 8 mg
Oral Ondansetron 8 mg administered in a single does dose during gastric emptying and duodenal infusion.
Experimental: Diabetic (DM) gastroenteropathy Ondansetron 8 mg
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
Experimental: Non-ulcer dyspepsia (NUD) Ondansetron 8 mg
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
Placebo_comparator: Healthy Control Placebo
Oral matched placebo administered in a single does dose during gastric emptying and duodenal infusion.
Placebo_comparator: Diabetic (DM) gastroenteropathy 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
Placebo_comparator: Non-ulcer dyspepsia (NUD) 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
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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