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

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

Tracking Information
First Submitted Date  ICMJE April 25, 2017
First Posted Date  ICMJE April 28, 2017
Last Update Posted Date April 28, 2017
Actual Study Start Date  ICMJE October 3, 2016
Estimated Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2017)
Eradication of Helicobacter pylori infection [ Time Frame: 4 weeks after completed therapy ]
Urea Breath Test after therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 10 vs 14 Days Triple Therapy : H.Pylori Infection Eradication
Official Title  ICMJE Comparison of Triple Therapy Regimens Effectiveness Over 10 Days and 14 Days in Eradication of Helicobacter Pylori Infection: Double Blind Randomized Clinical Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomized-double blinded Clinical Trials
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 14 days triple therapy
    Rabeprazole Clarithromycin Amoxicillin
    Interventions:
    • Drug: Rabeprazole Sodium 20mg
    • Drug: Clarithromycin 500mg
    • Drug: Amoxicillin 500 Mg
  • Placebo Comparator: 10 days triple therapy
    Rabeprazole Clarithromycin Amoxicillin
    Interventions:
    • Drug: Rabeprazole Sodium 20mg
    • Drug: Clarithromycin 500mg
    • Drug: Amoxicillin 500 Mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 27, 2017)
73
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 12, 2017
Estimated Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03134378
Other Study ID Numbers  ICMJE 16-10-311
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ari Fahrial Syam, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indonesia University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP