Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection
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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 |
- 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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Byron Cryer, MD | 214-857-1603 | byron.cryer@utsouthwestern.edu |
| Contact: Elizabeth Coss, MD | 817-896-7030 | elizabeth.coss@phhs.org |
| United States, Texas | |
| Dallas VAMC | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Byron Cryer, MD byron.cryer@utsouthwestern.edu | |
| 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 June 17, 2013