Concomitant Therapy of H. Pylori

Gastritis, Gastric Ulcer, and Duodenal Ulcer Clinical Trial

Official title:

Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01922765
• Other study ID #: concomitant
• Status: Recruiting
• Phase: Phase 4
• First received: August 12, 2013
• Last updated: February 9, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Education, Science, and Technology
• Study type: Interventional

Clinical Trial Summary

If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.

Description:

• Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori

• 170 subjects per group

• Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients infected with Helicobacter pylori

Exclusion Criteria:

• cancer

• pregnancy

• formerly treated with eradication

Study Design

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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastritis, Gastric Ulcer, and Duodenal Ulcer
• Stomach Ulcer

Intervention

Drug:
• amoxicillin, clarithromycin, metronidazole, rabeprazole

Locations

Country	Name	City	State
Korea, Republic of	Yeouido St. Mary's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
The Catholic University of Korea	Bucheon St. Mary's Hospital, St. Vincent's Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori	measure eradication rate of H.pylori with urea breath test(UBT) after 6 to 8 weeks of treatment	6 months (Feb 2014)	No