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A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT01219764
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Ala'a Sharara, American University of Beirut Medical Center

Study Description
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Brief Summary:

The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis.

Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.


Condition or disease Intervention/treatment Phase
Helicobacter Infections Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin Phase 4

Detailed Description:

Infection with H. pylori has been linked with chronic active gastritis, peptic ulcer disease, adenocarcinoma and Non-Hodgkin's lymphoma of the stomach. Eradication of this organism has been recommended for patients with peptic ulcer disease, low-grade gastric mucosa-associated lymphoid tissue lymphoma, atrophic gastritis, unexplained iron deficiency anemia, chronic idiopathic thrombocytopenic purpura, as well as first-degree relatives of gastric cancer patients.

Guidelines still recommend using triple therapy regimen of PPI, clarithromycin and amoxicillin/metronidazole twice daily for 7 to 14 days. Over the years, it has become clear that the first-line triple therapy is loosing efficacy worldwide with PP and ITT eradication rates inferior to 80%. Antimicrobial resistance plays an important role in some of these failures.

Major H. pylori study groups in the world have agreed that alternative treatment regimens are urgently needed. So far, 2 alternative treatment regimens have shown superiority over the first-line treatment protocols: the sequential therapy consisting of a combination of amoxicillin and a PPI twice a day for 5 days followed by another 5 days of the PPI plus clarithromycin and tinidazole/metronidazole, and the concomitant non-bismuth quadruple regimen consisting of PPI, clarithromycin, metronidazole, and amoxicillin twice daily.

The proposed study will test the hypothesis that H. pylori can be eradicated successfully (>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen: rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in patients with peptic ulcers and H. pylori related gastritis.

Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests, documenting H.pylori infection, will be randomized into one of two groups: Full dose or half dose the concomitant regimen, with 100 patients in each group. Compliance and side effects will be assessed, and a urea breath test will be done for all patients after 4 weeks of therapy completion to evaluate eradication rates. Success of therapy will be evaluated according to intent-to treat and per-protocol analyses.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
Study Start Date : October 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Full Dose
Full dose of Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days.
 Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin

Full dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days.

Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days.

Other Names:
  • Rabeprazole: Pariet
  • Metronidazole: Flagyl
  • Clarithromycin: Klacid
  • Amoxicillin: Amoxil
Experimental: Half dose
Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days.
 Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin

Full dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days.

Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days.

Other Names:
  • Rabeprazole: Pariet
  • Metronidazole: Flagyl
  • Clarithromycin: Klacid
  • Amoxicillin: Amoxil


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with negative urea breath test post treatment [ Time Frame: 30 days post treatment completion ]
    30 days post treatment completion, patients will do a Urea Breath Test (a test that is regularly used to check for H. Pylori infection in the stomach) to check whether H. Pylori has been eradicated from the stomach or not.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: during the 7 days of the treatment ]
    we will check for nausea, vomiting, metallic taste, diarrhea, and abdominal pain during the 7 days of the treatment period in each patient.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented H.pylori infection by a CLO test or a Urea Breath Test
  • sign the informed consent

Exclusion Criteria:

  • Age under 18 or older than 80 years
  • Allergies to any of the drugs used
  • Recent antibiotic therapy (within 2 weeks of enrolment)
  • Severe ulcers or bleeding
  • Gastric perforation or obstruction
  • Previous gastrectomy
  • Gastric cancer
  • Pregnancy or lactation
  • Prior eradication therapy for H. pylori
  • Severe concomitant disease or condition making the treatment unlikely to be effective i.e. alcoholism, drug addiction, and history of poor compliance.
Contacts and Locations
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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): NCT01219764


Locations
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Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Ala' I Sharara, MD American University of Beirut Medical Center
More Information
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Responsible Party: Ala'a Sharara, Professor of Medicine, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01219764    
Other Study ID Numbers: IM.AS1.25
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014
Keywords provided by Ala'a Sharara, American University of Beirut Medical Center:
Helicobacter pylori infection
quadruple therapy
Amoxicillin
 Metronidazole
Clarithromycin
Rabeprazole
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
 Antiprotozoal Agents
Antiparasitic 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