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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Dallas VA Medical Center.
Recruitment status was:  Recruiting
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Byron Cryer, Dallas VA Medical Center Identifier:
First received: November 5, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
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.

Condition Intervention
Helicobacter Infection
Drug: Standard Triple Therapy
Drug: Sequential Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection

Resource links provided by NLM:

Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • Helicobacter pylori eradication [ Time Frame: 4 weeks after completion of treatment ]

Estimated Enrollment: 184
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Please refer to this study by its identifier: NCT01723059

Contact: Byron Cryer, MD 214-857-1603
Contact: Elizabeth Coss, MD 817-896-7030

United States, Texas
Dallas VAMC Recruiting
Dallas, Texas, United States, 75216
Contact: Byron Cryer, MD   
Sponsors and Collaborators
Dallas VA Medical Center
Otsuka Pharmaceutical Development & Commercialization, Inc.
Principal Investigator: Byron Cryer, MD Gastroenterologist, MD VA
Study Chair: Robert Genta, MD Pathologist, MD
Study Chair: Elizabeth Coss, MD Gastroenterology Fellow, MD
  More Information

Responsible Party: Byron Cryer, Staff Gastroenterologist, Dallas VA Medical Center Identifier: NCT01723059     History of Changes
Other Study ID Numbers: 11-060
Study First Received: November 5, 2012
Last Updated: November 5, 2012

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antiprotozoal Agents
Antiparasitic Agents processed this record on April 28, 2017