BridgeMD
New treatment option for Indigestion
Official title Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
ClinicalTrials.gov ID: NCT03865290
What this study is testing
What is Ondansetron 8mg?
Ondansetron 8mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for indigestion.
Also referred to as Zofran.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)
You likely can't join if
- Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, herniorrhaphy, and limited colonic resection are...
- Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological...
- Current use of opiates, alpha adrenergic agonists, metoclopramide, monoamine oxidase inhibitors, more than one serotonergic medication, and high...
- 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),
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.