NCT01723059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

11 months

First QC Date

November 5, 2012

Last Update Submit

November 5, 2012

Conditions

Helicobacter Infection

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori eradication

    4 weeks after completion of treatment

Study Arms (2)

Standard triple therapy

OTHER

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

Sequential Therapy

ACTIVE COMPARATOR

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

Interventions

Standard Triple TherapyDRUG

for 10 days

Also known as: Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice daily
Standard triple therapy
Sequential TherapyDRUG

total 10 days

Also known as: 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
Sequential Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VAMC

Dallas, Texas, 75216, United States

RECRUITING

MeSH Terms

Conditions

Helicobacter Infections

Interventions

AmoxicillinOmeprazoleClarithromycintechnetium Tc 99m 1,6-di-(2-thienyl)-2,5-diazahexaneMetronidazole

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesHeterocyclic Compounds, 1-RingBenzimidazolesErythromycinMacrolidesPolyketidesLactonesNitroimidazolesNitro CompoundsImidazolesAzoles

Study Officials

  • Byron Cryer, MD

    Gastroenterologist, MD VA

    PRINCIPAL INVESTIGATOR

  • Robert Genta, MD

    Pathologist, MD

    STUDY CHAIR

  • Elizabeth Coss, MD

    Gastroenterology Fellow, MD

    STUDY CHAIR

Central Study Contacts

Byron Cryer, MD

CONTACT

214-857-1603byron.cryer@utsouthwestern.edu

Elizabeth Coss, MD

CONTACT

817-896-7030elizabeth.coss@phhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Gastroenterologist

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

US(1)