NCT01061437

S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)

A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,859 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

Detailed description

Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	PACx14	Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
DRUG	PACMx5	Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)
DRUG	PAx5/PCMx5	Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-02-03
• Last updated: 2012-09-26

Locations

7 sites across 6 countries: Chile, Colombia, Costa Rica, Honduras, Mexico, Nicaragua