Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Helicobacter pylori eradication [4 weeks after completion of treatment]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dallas VAMC | Dallas | Texas | United States | 75216 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11-060