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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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31 October 2016 |
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Main ID: |
NCT02934152 |
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Date of registration:
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06/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication
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Scientific title:
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Symptom Assessment for Patients With Gastro-esophageal Reflux Disease Receiving Helicobacter Pylori Eradication |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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400 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02934152 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Ping-Huei Tseng, MDPHD |
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Address:
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Telephone:
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886-972652009 |
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Email:
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pinghuei@ntu.edu.tw |
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Affiliation:
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Name:
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Ping-Huei Tseng , MDPHD |
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Address:
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Telephone:
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886-972652009 |
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Email:
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pinghuei@ntu.edu.tw |
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Affiliation:
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Name:
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Ping-Huei Tseng, MDPHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) validated
by standard questionnaire GerdQ.16
2. Aged >= 20 years old.
3. Willing to receive H. pylori eradication therapy.
Exclusion criteria:
1. Symptomatic reflux patients with high grade erosive esophagitis (LA classification
Grade C and D) or Barrett's esophagus documented by endoscopy.
2. Symptomatic reflux patients with a history of using PPI in recent one month.
3. Subjects with known allergy to PPI.
4. Peptic ulcer disease
5. Cancers of the esophagus, stomach, and duodenum
6. Esophageal or gastric varices
7. Active upper gastrointestinal bleeding within 7 days prior to enrollment
8. Status after total or subtotal gastrectomy
9. Pregnancy
10. Use of anticoagulants or antiplatelets within one week prior to enrollment
11. Subjects with bleeding tendency
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Reflux Disease
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Intervention(s)
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Drug: H pylori eradication
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Other: H pylori eradication timing
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Primary Outcome(s)
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Acid rebound
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Severity of acid rebound
[Time Frame: 4 weeks]
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Secondary ID(s)
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201607055MINC
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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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