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Trial record 27 of 4002 for:    Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication

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ClinicalTrials.gov Identifier: NCT03134378
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ari Fahrial Syam, Indonesia University

Brief Summary:
Helicobacter pylori is a bacterium estimated to colonize in the gastrointestinal tract of the half population in the world. Colonization of this bacteria is suspected to be one of the main risk factor for the occurrence of various abnormalities of the upper gastrointestinal tract, such as peptic ulcer and gastrointestinal cancer. The Experts recommend giving triple therapy regimens as first-line eradication therapy for Helicobacter pylori infection. The recommended duration of triple therapy is 10-14 days. However, recent studies suggest triple therapy with longer duration will provide a higher percentage of eradication. This study wanted to show whether 14 days of triple therapy was better than 10 days in Helicobacter pylori eradication.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Rabeprazole Sodium 20mg Drug: Clarithromycin 500mg Drug: Amoxicillin 500 Mg Phase 4

Detailed Description:

This is a double-blinded randomized clinical trials, to determine the proportion of eradication of Helicobacter pylori infection using a triple therapy regimen for 10 days and 14 days. The triple therapy regimen was a proton pump inhibitor (Rabeprazole 20 mg twice daily), Amoxicillin 1000 mg twice daily, and Clarithromycin 500 mg twice daily.

Patients with dyspepsia and no improvement for at least 2 weeks with empiric therapy (lifestyle education, antacid, H2-antagonist, or proton pump inhibitor), are further investigated to determine the presence of Helicobacter pylori infection using invasive (Esophagoduodenoscopy/EGD) or non-invasive methods (Urea Breath Test/UBT).

Patients with positive results on UBT or histology examination from EGD and fulfill inclusion and exclusion criteria are included as research subjects, then randomly assigned to determine the subject of the study into the sample of study entry in group 1 or group 2.

All subjects will be required to fill out informed consent, demographic data, anthropometric measurements, and questionnaires.

Research subjects will get triple therapy regimen for Helicobacter pylori infection in the form of Proton Pump Inhibitor (Rabeprazole 2 x 20 mg), Amoxicillin 2 x 1000 mg, and Clarithromycin 2 x 500 mg.

Pharmacy will create two sets of regimens, in which one group of regimens contains triple therapy regimens for 10 days followed by the same regimen for 4 days, while another regimen group contains triple therapy regimens for 10 days Day followed by placebo for 4 days. Neither the researcher nor the study subjects knew the triple therapy regimen given to group 1 and group 2 subjects, and only became known after the end of the study.

All subjects will be monitored given drug consumption and evaluated regularity, complaints, and adverse effects arising for 14 days by researchers. The patient is given a control card to write down medication time and any possible complaints or side effects of drug allergic reactions, epigastric pain, headache, discomfort, and nausea / vomiting, and other side effects will be observed during the study. The patient will be determined whether the study will continue or not.

After the therapy was completed, the subjects of the study will be re-examined as an evaluation of eradication success, at least 28 days after completion of triple therapy regimen.

If UBT negative results obtained at the time of evaluation, the eradication is success, when positive UBT results are obtained at the time of evaluation, eradication is failed and the subjects are persistent with first-line therapy.

Persistent patients are encouraged to undergo an EGD at Cipto Mangunkusumo Hospital for the culture of Helicobacter pylori infection resistance. If the patient is not willing to be underwent EGD, then the patient is given second-line treatment regimen of Levofloxacin 2 x 500 mg, Amoxicillin 2 x 1000 mg, and Rabeprazole 2 x 20mg.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized-double blinded Clinical Trials
Primary Purpose: Treatment
Official Title: Comparison of Triple Therapy Regimens Effectiveness Over 10 Days and 14 Days in Eradication of Helicobacter Pylori Infection: Double Blind Randomized Clinical Trial
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : May 5, 2017
Estimated Study Completion Date : May 12, 2017


Arm Intervention/treatment
Experimental: 14 days triple therapy
Rabeprazole Clarithromycin Amoxicillin
Drug: Rabeprazole Sodium 20mg
Twice daily
Other Name: Pariet

Drug: Clarithromycin 500mg
Twice daily
Other Name: Bicrolid

Drug: Amoxicillin 500 Mg
Twice daily
Other Name: Amoxicillin generic

Placebo Comparator: 10 days triple therapy
Rabeprazole Clarithromycin Amoxicillin
Drug: Rabeprazole Sodium 20mg
Twice daily
Other Name: Pariet

Drug: Clarithromycin 500mg
Twice daily
Other Name: Bicrolid

Drug: Amoxicillin 500 Mg
Twice daily
Other Name: Amoxicillin generic




Primary Outcome Measures :
  1. Eradication of Helicobacter pylori infection [ Time Frame: 4 weeks after completed therapy ]
    Urea Breath Test after therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older patients who are proven to be infected by Helicobacter pylori based on positive in Urea Breath Test or positive in histopathologic examination of biopsy in antrum and corpus of gaster through esophagoduodenoscopy.

Exclusion Criteria:

  • Patients refuse to follow the research
  • Patient has had previous eradication therapy of Helicobacter pylori infection.
  • The patient is pregnant or breastfeeding
  • Patients have a history of allergy to one component of triple therapy regimen (proton pump inhibitor, penicillin, and / or macrolide) before.
  • Patients are known to have impaired liver function, evidenced by ALT values within normal limits, and no previous liver disease.
  • Patients were found to have arrhythmias or obtained QT wave elongation on electrocardiographic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134378


Contacts
Contact: Ari F Syam, Dr. +62818706199 ari_syam@hotmail.com
Contact: Ryan Herardi, dr. +6281585089087 ryanhemail@gmail.com

Locations
Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Ari F Syam, Dr.    +62818706199    ari_syam@hotmail.com   
Contact: Ryan Herardi, dr.    +6281585089087    ryanhemail@gmail.com   
Sponsors and Collaborators
Indonesia University

Responsible Party: Ari Fahrial Syam, Dr. dr. SpPD, K-GEH, MMB, FACP, Indonesia University
ClinicalTrials.gov Identifier: NCT03134378     History of Changes
Other Study ID Numbers: 16-10-311
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ari Fahrial Syam, Indonesia University:
Helicobacter pylori
triple therapy
eradication

Additional relevant MeSH terms:
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors