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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ala'a Sharara, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01219764
First received: May 19, 2010
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Helicobacter Infections
Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • Number of participants with negative urea breath test post treatment [ Time Frame: 30 days post treatment completion ] [ Designated as safety issue: No ]
    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:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: during the 7 days of the treatment ] [ Designated as safety issue: Yes ]
    we will check for nausea, vomiting, metallic taste, diarrhea, and abdominal pain during the 7 days of the treatment period in each patient.


Enrollment: 200
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219764

Locations
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Ala' I Sharara, MD American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Ala'a Sharara, Professor of Medicine, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01219764     History of Changes
Other Study ID Numbers: IM.AS1.25
Study First Received: May 19, 2010
Last Updated: January 24, 2014
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Helicobacter pylori infection
quadruple therapy
Amoxicillin
Metronidazole
Clarithromycin
Rabeprazole

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Infection
Bacterial Infections
Gram-Negative Bacterial Infections
Amoxicillin
Clarithromycin
Metronidazole
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Proton Pump Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014