Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection

Helicobacter Infection Clinical Trial

Official title:

Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01723059
• Other study ID #: 11-060
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2012
• Last updated: November 5, 2012
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: November 2012
• Source: Dallas VA Medical Center
• Contact: Byron Cryer, MD
• Phone: 214-857-1603
• Email: byron.cryer[@]utsouthwestern.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Subject has signed informed consent Subject is an adult older than 18 yrs old and requires an upper endoscopic evaluation If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Patient has not received prior treatment for H pylori Subject is able to understand and comply with study procedures

Exclusion Criteria:

Recent use (within 4 weeks) of any of the medications used in the treatment of H pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute gastrointestinal bleeding Subject has an allergy to any of the medications used in the treatment of H pylori Subject has a history of esophageal or gastric carcinoma including lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication

Study Design

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

Related Conditions & MeSH terms

• Helicobacter Infection
• Helicobacter Infections
• Infection

Intervention

Drug:
• Standard Triple Therapy
for 10 days
• Sequential Therapy
total 10 days

Locations

Country	Name	City	State
United States	Dallas VAMC	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dallas VA Medical Center	Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication		4 weeks after completion of treatment	Yes