DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: American University of Beirut Medical Center
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Infections

Intervention: Rabeprazole, metronidazole, Clarithromycin, Amoxicillin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: American University of Beirut Medical Center

Official(s) and/or principal investigator(s):
Ala' I Sharara, MD, Principal Investigator, Affiliation: American University of Beirut Medical Center

Overall contact:
Ala' I Sharara, MD, Phone: +9611350000, Ext: 5345, Email: as08@aub.edu.lb

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with negative urea breath test post treatment

Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Ala' I Sharara, MD, Phone: +9611350000, Ext: 5345, Email: as08@aub.edu.lb

American University of Beirut - Medical Center, Beirut, Lebanon; Recruiting
Ala I Sharara, MD, Phone: 009611350000, Ext: 5400, Email: as08@aub.edu.lb
Ala' I Sharara, MD, Principal Investigator
Additional Information

Starting date: October 2010
Last updated: March 22, 2011

Page last updated: December 08, 2011

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012