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NCT04525664 · ClinicalTrials.gov registry record · Early Phase 1
Assessment and Management of Chronic Dyspepsia in Eastern Uganda
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 376
- Enrollment target
NCT04525664 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 376 participants.
The verdict
NCT04525664, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 376 participants
- Enrollment target
Study Summary
Chronic dyspepsia, or a sensation of indigestion, remains an underdiagnosed and often inappropriately managed cause of morbidity in countries with limited medical resources. A recent questionnaire of Eastern Ugandan residents identified chronic dyspepsia as the most bothersome symptom in nearly 60% of respondents, resulting in significant morbidity and work days missed. One of the most common causes for chronic dyspepsia worldwide is infection with the stomach-adapted bacterium Helicobacter pylori (Hp), the most significant risk factor for the development of stomach cancer. In developing countries, particularly in sub-Saharan Africa, the prevalence of Hp has not been accurately determined, often owing to a lack of adequate diagnostic methods. More importantly, proper diagnosis and treatment of chronic dyspepsia would limit morbidity and mortality and help decrease the likelihood of progressing to stomach cancer. The purposes of this study are to identify the prevalence of chronic dyspepsia among residents of eastern Uganda using a questionnaire, to assess how common Hp infection is using fecal Hp antigen test kits, and to evaluate the efficacy of Hp eradication using standard Ugandan treatment guidelines. Participants who test positive for Hp infection by fecal Hp antigen testing will be offered Hp eradication treatment in the form of two antibiotics (clarithromycin, amoxicillin) and an acid-suppression medication (omeprazole), according to the current Ugandan guidelines. Patients with chronic dyspepsia who are negative for Hp (by fecal antigen testing) will be given a one-month trial of omeprazole alone, according to current American College of Gastroenterology guidelines, and their symptoms will be reassessed. At the end of the treatment regimens, participants will have the option to complete a follow-up questionnaire and provide stool samples for fecal antigen testing (if they were Hp-positive).
Interventions
- DRUG Clarithromycin 500mg
- DRUG Omeprazole 40 MG
- DRUG Amoxicillin 1000 MG
- DRUG Omeprazole 20 MG Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2020-06-30 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04525664
The ClinicalTrials.gov registry entry for NCT04525664 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 376 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Clarithromycin 500mg is the first listed.
NCT04525664 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04525664 about?
NCT04525664 is a clinical study titled "Assessment and Management of Chronic Dyspepsia in Eastern Uganda". Chronic dyspepsia, or a sensation of indigestion, remains an underdiagnosed and often inappropriately managed cause of morbidity in countries with limited medical resources. A recent questionnaire of Eastern Ugandan residents identified chronic dyspepsia as the most bothersome symptom in nearly 60% ...
What is the current status of trial NCT04525664?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 376 participants. The study started on 2018-10-01. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT04525664?
The interventions under investigation include: Clarithromycin 500mg (DRUG), Omeprazole 40 MG (DRUG), Amoxicillin 1000 MG (DRUG), Omeprazole 20 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04525664?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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