MedDataX Logo

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

NCT ID: NCT01723059

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Standard Triple Therapy

Intervention Type DRUG

for 10 days

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.

Group Type ACTIVE_COMPARATOR

Sequential Therapy

Intervention Type DRUG

total 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Triple Therapy

for 10 days

Intervention Type DRUG

Sequential Therapy

total 10 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role collaborator

Dallas VA Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Byron Cryer

Staff Gastroenterologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Byron Cryer, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterologist, MD VA

Robert Genta, MD

Role: STUDY_CHAIR

Pathologist, MD

Elizabeth Coss, MD

Role: STUDY_CHAIR

Gastroenterology Fellow, MD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dallas VAMC

Dallas, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Byron Cryer, MD

Role: CONTACT

Phone: 214-857-1603

Email: [email protected]

Elizabeth Coss, MD

Role: CONTACT

Phone: 817-896-7030

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Byron Cryer, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-060

Identifier Type: -

Identifier Source: org_study_id