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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Triple Therapy | Drug | for 10 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication | 4 weeks after completion of treatment |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byron Cryer, MD | Contact | 214-857-1603 | byron.cryer@utsouthwestern.edu | |
| Elizabeth Coss, MD | Contact | 817-896-7030 | elizabeth.coss@phhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Byron Cryer, MD | Gastroenterologist, MD VA | Principal Investigator |
| Robert Genta, MD | Pathologist, MD | Study Chair |
| Elizabeth Coss, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas VAMC | Recruiting | Dallas | Texas | 75216 | United States |
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| ID | Term |
|---|---|
| D016481 | Helicobacter Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D009853 | Omeprazole |
| D017291 | Clarithromycin |
| C107828 | technetium Tc 99m 1,6-di-(2-thienyl)-2,5-diazahexane |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Sequential Therapy | Drug | total 10 days |
|
|
| Gastroenterology Fellow, MD |
| Study Chair |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |