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

NCT01219764 | Completed Phase 4 DMC

• 1 other identifier: IM.AS1.25
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Infections

Keywords

Helicobacter pylori infection; quadruple therapy; Amoxicillin; Metronidazole; Clarithromycin; Rabeprazole

Outcome Measures

Primary Outcomes (1)

• Number of participants with negative urea breath test post treatment

  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.

  30 days post treatment completion

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  during the 7 days of the treatment

Study Arms (2)

Full Dose

ACTIVE COMPARATOR

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

Half dose

EXPERIMENTAL

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

Drug: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin

Interventions

Rabeprazole, metronidazole, Clarithromycin, Amoxicillin DRUG

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.

Also known as: Rabeprazole: Pariet, Metronidazole: Flagyl, Clarithromycin: Klacid, Amoxicillin: Amoxil

Full Dose; Half dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut - Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Rabeprazole; Metronidazole; Clarithromycin; Amoxicillin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Ala' I Sharara, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

LE (1)