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

Primary Purpose

Helicobacter Infection

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Triple Therapy

Sequential Therapy

About this trial

This is an interventional treatment trial for Helicobacter Infection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dallas VAMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Standard triple therapy

Sequential Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Helicobacter pylori eradication

Secondary Outcome Measures

Full Information

NCT ID

NCT01723059

First Posted

November 5, 2012

Last Updated

November 5, 2012

Sponsor

Dallas VA Medical Center

Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01723059

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dallas VA Medical Center

Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard triple therapy

Arm Type

Other

Arm Description

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.

Arm Title

Sequential Therapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Standard Triple Therapy

Other Intervention Name(s)

Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice daily

Intervention Description

for 10 days

Intervention Type

Drug

Intervention Name(s)

Sequential Therapy

Other Intervention Name(s)

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

Intervention Description

total 10 days

Primary Outcome Measure Information:

Title

Helicobacter pylori eradication

Time Frame

4 weeks after completion of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Byron Cryer, MD

Phone

214-857-1603

byron.cryer@utsouthwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Elizabeth Coss, MD

Phone

817-896-7030

elizabeth.coss@phhs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byron Cryer, MD

Organizational Affiliation

Gastroenterologist, MD VA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Genta, MD

Organizational Affiliation

Pathologist, MD

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Elizabeth Coss, MD

Organizational Affiliation

Gastroenterology Fellow, MD

Official's Role

Study Chair

Facility Information:

Facility Name

Dallas VAMC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Byron Cryer, MD

byron.cryer@utsouthwestern.edu

12. IPD Sharing Statement

Learn more about this trial

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

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