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

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

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Infection
• Intervention / Treatment: Drug: Standard Triple Therapy; Drug: Sequential Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Byron Cryer, MD; Phone Number: 214-857-1603; Email: byron.cryer@utsouthwestern.edu
• Study Contact Backup: Name: Elizabeth Coss, MD; Phone Number: 817-896-7030; Email: elizabeth.coss@phhs.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • Recruiting
      • Dallas VAMC
      • Contact: Byron Cryer, MD; Email: byron.cryer@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard triple therapy; Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days.	Drug: Standard Triple Therapy; for 10 days; Other Names: Amoxicillin 1000 mg orally twice daily; Omeprazole 20 mg orally twice daily; Clarithromycin 500 mg orally twice daily
Active Comparator: Sequential Therapy; Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days.	Drug: Sequential Therapy; total 10 days; Other Names: Amoxicillin 1000 mg orally twice daily for 5 days; Omeprazole 20 mg orally twice daily for 5 days; Then; Clarithromycin 500 mg orally twice daily for 5 days; Metronidazole 500 mg orally twice daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Helicobacter pylori eradication	4 weeks after completion of treatment

Collaborators and Investigators

• Sponsor: Dallas VA Medical Center
• Collaborators: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Principal Investigator: Byron Cryer, MD, Gastroenterologist, MD VA; Study Chair: Robert Genta, MD, Pathologist, MD; Study Chair: Elizabeth Coss, MD, Gastroenterology Fellow, MD

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Estimate): November 7, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Amoxicillin; Clarithromycin; Omeprazole
• Other Study ID Numbers: 11-060