NCT03865290 Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
| NCT ID | NCT03865290 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Indigestion |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-04-02 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2019-04-02 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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), * 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
Contact & Investigator
Adil E Bharucha, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT03865290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Indigestion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03865290 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03865290 currently recruiting?
Yes, NCT03865290 is actively recruiting participants. Contact the research team at Feuerhak.Kelly@mayo.edu for enrollment information.
Where is the NCT03865290 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT03865290 clinical trial?
NCT03865290 is sponsored by Mayo Clinic. The principal investigator is Adil E Bharucha, MD at Mayo Clinic. The trial plans to enroll 150 participants.