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

This study is currently recruiting participants.
Verified November 2012 by Dallas VA Medical Center
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
Byron Cryer, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT01723059
First received: November 5, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723059

Contacts
Contact: Byron Cryer, MD 214-857-1603 byron.cryer@utsouthwestern.edu
Contact: Elizabeth Coss, MD 817-896-7030 elizabeth.coss@phhs.org

Locations
United States, Texas
Dallas VAMC Recruiting
Dallas, Texas, United States, 75216
Contact: Byron Cryer, MD       byron.cryer@utsouthwestern.edu   
Sponsors and Collaborators
Dallas VA Medical Center
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
  More Information

No publications provided

Responsible Party: Byron Cryer, Staff Gastroenterologist, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01723059     History of Changes
Other Study ID Numbers: 11-060
Study First Received: November 5, 2012
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Metronidazole
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014