Clinical Trials Logo

Clinical Trial 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 Trial 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

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


Related Conditions & MeSH terms


NCT number NCT01219764
Study type Interventional
Source American University of Beirut Medical Center
Contact
Status Completed
Phase Phase 4
Start date October 2010
Completion date March 2013

See also
  Status Clinical Trial Phase
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Recruiting NCT03365609 - A Comparison of Four Different Treatment Regimens of Helicobacter Pylori in Chinese Children N/A
Completed NCT00005496 - Inflammation, Infection, and Future Cardiovascular Risk N/A
Completed NCT00216450 - Study of the Safety and Effectiveness of Rabeprazole in Treatment of Helicobacter Pylori Infection in Adults. Phase 4
Completed NCT00212225 - Risk Factors for Gastric Disease in Pediatric Helicobacter Pylori (H. Pylori) N/A
Completed NCT00083291 - Helicobacter Pylori and Dry Eye N/A
Not yet recruiting NCT04652284 - Effectiveness of Rifabutin for Treatment of Helicobacter Pylori Phase 3
Completed NCT02449941 - Helicobacter Pylori and Proton Pump Inhibitor N/A
Completed NCT02395458 - Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens Phase 4
Completed NCT00194688 - Breath Ammonia Method for H. Pylori Detection: Phase II Phase 2
Not yet recruiting NCT02126722 - Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy N/A
Active, not recruiting NCT01133951 - Helicobacter Pylori Eradication to Prevent Gastric Cancer N/A
Completed NCT00669955 - Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy Phase 3
Completed NCT00816140 - Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication Phase 4
Completed NCT00490386 - Helicobacter Pylori and Acute Alcohol Induced Pancreatitis N/A
Withdrawn NCT02645201 - The Effect of Probiotic Combination on Helicobacter Pylori Infection in Children N/A
Terminated NCT00664209 - Treating H. Pylori in Parkinson's Patients With Motor Fluctuations Phase 3
Completed NCT01792700 - Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy Phase 4
Completed NCT01922505 - Eradication Rates of Helicobacter Pylori and Its Affecting Factors Phase 4
Completed NCT02970110 - Specimen Collection Study for H. Pylori Testing