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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: |
NCT02249546 |
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Date of registration:
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18/09/2014 |
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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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Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
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Scientific title:
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Comparison of the Efficacy of Triple Therapy With or Without Acetylcysteine in the First Line of Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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654 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02249546 |
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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: 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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Chieh-Chang Chen, MD, MSc |
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Address:
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Telephone:
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886972652550 |
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Email:
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chiehchang.chen@gmail.com |
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Affiliation:
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Name:
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Chieh-Chang Chen, 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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Name:
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Ming-Shiang Wu, MD, PHD |
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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:
- H. pylori infected patients who have willingness to receive eradication therapy
Exclusion Criteria:
- (1) history of gastrectomy, (2)gastric malignancy, including adenocarcinoma and
lymphoma, (3) previous allergic reaction to antibiotics (amoxicillin,
clarithromycin), N-acetyl cysteine and prompt pump inhibitors (dexlansoprazole),
(4)contraindication to treatment drugs, (5) pregnant or lactating women, (6) severe
concurrent disease. (7) phenylketonuria (8) Patients who cannot give informed consent
by himself or herself.
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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Helicobacter Pylori Infection
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Intervention(s)
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Drug: PPI-amoxicillin-clarithromycin
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Drug: N-acetylcysteine + PPI-amoxicillin-clarithromycin
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Primary Outcome(s)
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Helicobacter pylori eradication rate
[Time Frame: 6wks]
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Secondary Outcome(s)
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Compliance
[Time Frame: 14 days]
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Adverse effects
[Time Frame: 14 days]
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Secondary ID(s)
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201406074MINC
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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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