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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03521726 |
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Date of registration:
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22/04/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intraluminal Amoxicillin Powder Monotherapy for Helicobacter Pylori Infection
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Scientific title:
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Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan |
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Date of first enrolment:
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May 11, 2018 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03521726 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Tai-cherng Liou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients aged greater than 20 years and less than 75 years
2. Patients have H. pylori infection without prior eradication therapy
3. Patients are willing to receive the intraluminal therapy. The written informed
consents will be obtained from all patients prior to enrollment.
Exclusion Criteria:
1. Children and teenagers aged less than 20 years, and adult greater than 75 years
2. Contraindication for endoscopic examination or food retention in the gastric lumen.
3. History of gastrectomy; Gastroduodenal stenosis?deformity or obstruction;
Gastroduodenal malignancy, including adenocarcinoma and lymphoma
4. Contraindication to treatment drugs: previous allergic reaction to amoxicillin, Proton
pump inhibitors (lansoprazole, rabeprazole), Acetylcystein and Sucralfate; pregnant or
lactating women
5. Severe concurrent acute or chronic illness: renal failure, cirrhosis of liver,
incurable malignant disease
6. Patients who cannot give informed consent by himself or herself.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Helicobacter Pylori Infection
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Intervention(s)
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Drug: Amoxicillin
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Drug: Rabeprazole, Amoxicillin
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Primary Outcome(s)
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Eradication rate in the intraluminal therapy
[Time Frame: 6 weeks after finishing therapy]
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Secondary Outcome(s)
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Overall eradication rates
[Time Frame: 3-6 months after finishing intraluminal therapy]
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Secondary ID(s)
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17MMHIS096
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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