A Phase 4 interventional study of 7-day quadruple therapy and 10-day sequential therapy in Helicobacter Pylori Infection, sponsored by Kaohsiung Veterans General Hospital.. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by Kaohsiung Veterans General Hospital. · Phase 4, Interventional, and Treatment
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.
A total of 306 subjects are enrolled into this study.
H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 307 is above the median of 120 across 4,200 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days, 4. metronidazole 500 mg twice daily for 7 days
Drug: 7-day quadruple therapy
1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by 2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days.
Drug: 10-day sequential therapy
1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days.
Drug: 7-day standard triple therapy
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
Also known as: Pantoprazole, amoxicillin, clarithromycin, metronidazole
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
Also known as: sequential group
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Also known as: pantoprazole, clarithromycin, amoxicillin
Number of Participants With Complete Eradication of Helicobacter Pylori
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Time frame: at the 6th week after the end of anti- H. pylori therapy
We surveyed patients who visited the gastroenterological clinic of Kaohsiung Medical University Hospital (KMUH), Kaohsiung Veteran General Hospital (KVGH). A total of 307 H. pylori-infected patients were randomly assigned to triple (n=103 ) or sequential (n = 102) or concomitant (n = 102) therapies.
| Milestone | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy |
|---|---|---|---|
| Started | 102 | 102 | 103 |
| Completed | 102 | 100 | 101 |
| Not completed | 0 | 2 | 2 |
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
| participants | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy |
|---|---|---|---|
| Number of Participants With Complete Eradication of Helicobacter Pylori | 102 | 100 | 101 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 7-day Quadruple Therapy | — | 0/102 (0%) | 14/102 (13.7%) |
| 10-day Sequential Therapy | — | 0/102 (0%) | 9/102 (8.8%) |
| 7-day Standard Triple Therapy | — | 0/103 (0%) | 9/103 (8.7%) |
| Event | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy |
|---|---|---|---|
| NauseaGastrointestinal disorders | 7/102 | 5/102 | 3/103 |
| VomitingGastrointestinal disorders | 7/102 | 4/102 | 4/103 |
| DiarrheaGastrointestinal disorders | 1/102 | 0/102 | 3/103 |
| Age, Categorical(Participants) | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 74 | 68 | 69 | 211 |
| >=65 years | 28 | 34 | 34 | 96 |
| Age, Continuous(years) | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy | Total |
|---|---|---|---|---|
| Mean | 53.85 ± 12.31 | 54.96 ± 12.00 | 56.08 ± 14.00 | 54.88 ± 12.73 |
| Sex: Female, Male(Participants) | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy | Total |
|---|---|---|---|---|
| Female | 41 | 50 | 41 | 132 |
| Male | 61 | 52 | 62 | 175 |
| Region of Enrollment(participants) | 7-day Quadruple Therapy | 10-day Sequential Therapy | 7-day Standard Triple Therapy | Total |
|---|---|---|---|---|
| Taiwan | 102 | 102 | 103 | 307 |
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.