A Phase 4 interventional study of 14-day sequential treatment and 14-day hybrid treatment in Helicobacter Pylori Infection, sponsored by Kaohsiung Veterans General Hospital.. Completed at 2 sites in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-09-21.
Sponsored by Kaohsiung Veterans General Hospital. · Phase 4, Interventional, and Treatment
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.
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%.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 240 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
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
* 14-day sequential therapy arm: 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 * 14-day hybrid therapy arm: 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
Also known as: Esomeprazole, amoxicillin, clarithromycin, metronidazole
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
Also known as: esomeprazole + amoxicillin, then quadruple therapy
Number of Participants in Which H. Pylori Was Eradicated
evaluate eradication outcome by endoscopy with urease test or urea breath test
Time frame: Dec 2010
Adverse Events
by standardized questionnaire
Time frame: Dec 2010
Compliance Rate
Good compliance is defined as taking equal or more than 90% of eradication medicines
Time frame: Dec 2010
recruitment period: Aug 2008 - May 2010
| Milestone | 14-day Sequential Treatment | 14-day Hybrid Treatment |
|---|---|---|
| Started | 123 | 117 |
| Completed | 123 | 117 |
| Not completed | 0 | 0 |
evaluate eradication outcome by endoscopy with urease test or urea breath test
| participants | 14-day Sequential Treatment | 14-day Hybrid Treatment |
|---|---|---|
| Number of Participants in Which H. Pylori Was Eradicated | 94 (90 to 98) | 99 (95 to 100) |
by standardized questionnaire
Results for this outcome have not been posted.
Good compliance is defined as taking equal or more than 90% of eradication medicines
Results for this outcome have not been posted.
Collected over period of data collection: 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 14-day Sequential Treatment | — | 0/123 (0%) | 26/123 (21.1%) |
| 14-day Hybrid Treatment | — | 0/117 (0%) | 17/117 (14.5%) |
| Event | 14-day Sequential Treatment | 14-day Hybrid Treatment |
|---|---|---|
| nauseaGastrointestinal disorders | 13/123 | 3/117 |
| Taste perversionGastrointestinal disorders | 11/123 | 8/117 |
| diarrheaGastrointestinal disorders | 4/123 | 8/117 |
| Age, Categorical(Participants) | 14-day Sequential Treatment | 14-day Hybrid Treatment | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 97 | 91 | 188 |
| >=65 years | 26 | 26 | 52 |
| Age, Continuous(years) | 14-day Sequential Treatment | 14-day Hybrid Treatment | Total |
|---|---|---|---|
| Mean | 55.1 ± 11.8 | 54.3 ± 11.4 | 54.7 ± 12.1 |
| Sex: Female, Male(Participants) | 14-day Sequential Treatment | 14-day Hybrid Treatment | Total |
|---|---|---|---|
| Female | 62 | 58 | 120 |
| Male | 61 | 59 | 120 |
| Region of Enrollment(participants) | 14-day Sequential Treatment | 14-day Hybrid Treatment | Total |
|---|---|---|---|
| Taiwan | 123 | 117 | 240 |
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Kaohsiung Veterans General Hospital.