Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children
NCT ID: NCT05861687
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
51 participants
INTERVENTIONAL
2021-08-01
2022-05-20
Brief Summary
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Detailed Description
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PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly selected as a drug of choice. Major influential factors such as Esomeprazole's additional antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. In terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous studies mention that children better tolerate PPIs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Esomeprazole in combination with Amoxicillin and Clarithromycin
Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Esomeprazole
Administered once a day per-oral (PO) with the dose of 0.4 mg/kg
Amoxicillin
Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
Clarithromycin
Administered twice a day per-oral with the dose of 7.5 mg/kg
Lansoprazole in combination with Amoxicillin and Clarithromycin
Lansoprazole: once a day per oral; 15 mg if body weight \< 30 kg and 30 mg if body weight \> 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg
Lansoprazole
Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was \<30 kg, and 30 mg if it was \>30 kg
Amoxicillin
Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
Clarithromycin
Administered twice a day per-oral with the dose of 7.5 mg/kg
Interventions
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Esomeprazole
Administered once a day per-oral (PO) with the dose of 0.4 mg/kg
Lansoprazole
Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was \<30 kg, and 30 mg if it was \>30 kg
Amoxicillin
Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
Clarithromycin
Administered twice a day per-oral with the dose of 7.5 mg/kg
Eligibility Criteria
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Inclusion Criteria
* Subject had been diagnosed with H.pylori infection prior to endoscopy and rapid urease testing
Exclusion Criteria
* subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment
* Incomplete triple pharmacologic treatment due to the subject's lack of medication adherence
2 Years
18 Years
ALL
No
Sponsors
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Finni Kollins
OTHER
Responsible Party
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Finni Kollins
Resident Doctor
Locations
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Universitas Sumatera Utara General Hospital
Medan, North Sumatera, Indonesia
Haji Adam Malik General Hospital
Medan, North Sumatera, Indonesia
Countries
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References
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Other Identifiers
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LB.02.01.XV.III.2.2.2/344/2022
Identifier Type: -
Identifier Source: org_study_id
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