Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Helicobacter Infection Clinical Trial

Official title:

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841854
• Other study ID #: 2008-0088
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2009
• Last updated: December 4, 2016
• Start date: June 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• H. pylori infection

• Aged between 18-80 years

• Are willing to received eradication therapy for H. pylori

Exclusion Criteria:

• Children and teenagers aged less than 18 years or over 80 years

• Previous eradication therapy for H. pylori

• History of gastrectomy

• Previous allergic reaction to antibiotics

• Use of prompt pump inhibitors and antibiotics in the recent 4 weeks

• Active upper GI bleeding in the recent 1 week

• Contraindication to treatment drugs

• Pregnant or lactating women

• Severe concurrent disease or malignancy

Study Design

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

Related Conditions & MeSH terms

• Helicobacter Infection
• Helicobacter Infections

Intervention

Drug:
• pantoprazole
pantoprazole 40mg bid
• bismuth
bismuth 300mg qid
• metronidazole
metronidazole 500mg tid
• tetracycline
tetracycline 500mg qid

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Asan Medical Center	Inje University, Pacific Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether the two week group yield a higher eradication rate comparing to the one week group.		At least four week after completion of treatment	No
Secondary	side effect		four weeks after completion of medication	Yes