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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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19 February 2015 |
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Main ID: |
NCT00990405 |
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Date of registration:
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05/10/2009 |
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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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Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
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Scientific title:
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Phase 4 Study of Helicobacter Pylori Eradication Therapy |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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400 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00990405 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), 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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Korea, Republic of
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Contacts
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Name:
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Sang-Young Seol, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korean Society of Helicobacter and Upper Gastrointestinal Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Functional dyspepsia by Rome III criteria
- Normal endoscopic findings
- H. pylori positive by Urea breath test
Exclusion Criteria:
- Patients with severe concomitant systemic disease
- Patients with GI surgery
- Females with pregnancy or breast-feeding
- Irritable bowel syndrome, inflammatory bowel disease
- Duodenal Ulcer, Gastric Ulcer, GI bleeding
- History of eradication therapy of Helicobacter pylori
- Malignancy
- Psychosomatic disease
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Functional Dyspepsia
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Helicobacter Pylori Infection
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Intervention(s)
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Drug: Lansoprzole+Amoxicillin+Clarithromycin
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Primary Outcome(s)
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Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
[Time Frame: Symptom assessment at 8 weeks after eradication]
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Secondary Outcome(s)
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Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy
[Time Frame: 1 year]
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The improvement of 8 dyspeptic symptom
[Time Frame: 1 year]
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To improves the quality of life
[Time Frame: 1 year]
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The adequate relief of symptom
[Time Frame: 1 year]
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Secondary ID(s)
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KoreanCHUGR05
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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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