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Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use

A

Ajou University School of Medicine

Status and phase

Unknown
Phase 4

Conditions

Helicobacter Eradication

Treatments

Drug: Helicobacter pylori eradication

Study type

Interventional

Funder types

Other

Identifiers

NCT01938534
AJOU-EIRB-152692

Details and patient eligibility

About

Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Full description

Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.

Enrollment

440 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Peptic ulcer disease
  • Gastric MALT lymphoma
  • Early gastric cancer
  • Familial history of gastric cancer
  • Idiopathic iron deficiency
  • Chronic idiopathic thrombocytopenia
  • Atrophic gastritis
  • Helicobacter infected dyspepsia
  • Long term NSAIDs use

Exclusion criteria

  • Pregnant
  • Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
  • Previous stomach surgery
  • Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
  • Previous Helicobacter eradication
  • Allergy for Helicobacter eradication medicine

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

440 participants in 2 patient groups

Experimental
Experimental group
Description:
Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days
Treatment:
Drug: Helicobacter pylori eradication
Control
Active Comparator group
Description:
Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days
Treatment:
Drug: Helicobacter pylori eradication

Trial contacts and locations

1

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Central trial contact

Sun Gyo Lim, M.D.; Ki Myung Lee, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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