Sequential and Hybrid Therapies for H Pylori Infection
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Purpose
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
| Condition | Intervention | Phase |
|---|---|---|
|
Helicobacter Pylori Infection |
Drug: 14-day sequential treatment Drug: 14-day hybrid treatment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection |
- Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: Dec 2010 ] [ Designated as safety issue: No ]evaluate eradication outcome by endoscopy with urease test or urea breath test
- Adverse Events [ Time Frame: Dec 2010 ] [ Designated as safety issue: Yes ]by standardized questionnaire
- Compliance Rate [ Time Frame: Dec 2010 ] [ Designated as safety issue: No ]Good compliance is defined as taking equal or more than 90% of eradication medicines
| Enrollment: | 240 |
| Study Start Date: | August 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 14-day sequential treatment
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
|
Drug: 14-day sequential treatment
Other Name: Esomeprazole, amoxicillin, clarithromycin, metronidazole
|
|
Experimental: 14-day hybrid treatment
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
|
Drug: 14-day hybrid treatment
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Other Name: esomeprazole + amoxicillin, then quadruple therapy
|
Detailed Description:
The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.
A total of 240 subjects will be asked to participate in this study.
H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).
Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.
A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria:
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women.
Contacts and Locations| Taiwan | |
| Kaohsiung Veterans General Hospital | |
| Kaohsiung, Taiwan | |
| Kaohsiung Veterans General Hospital | |
| Kaohsiung, Taiwan, 813 | |
| Study Chair: | Kwok-Hung Lai, PhD | Kaohsiung Veterans General Hospital. |
| Study Director: | David Y Graham, MD | Baylor College of Medicine |
| Principal Investigator: | PING-I Hsu, MD, PhD | Kaohsiung Veterans General Hospital. |
More Information
No publications provided
| Responsible Party: | PING-I HSU/Dr., Kaohsiung Veterans General Hospital |
| ClinicalTrials.gov Identifier: | NCT01085786 History of Changes |
| Other Study ID Numbers: | VGHKS97-CT6-08 |
| Study First Received: | March 11, 2010 |
| Results First Received: | April 12, 2011 |
| Last Updated: | April 12, 2011 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Kaohsiung Veterans General Hospital.:
|
Helicobacter pylori infection |
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 May 23, 2013