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High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed
Phase 4

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Esomeprazole
Drug: Amoxicillin
Drug: Metronidazole

Study type

Interventional

Funder types

Other

Identifiers

NCT04024527
rjyy20190715

Details and patient eligibility

About

Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.

Enrollment

306 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants with non-ulcer functional dyspepsia or peptic ulcer disease
  • Ability and willingness to participate in the study and to sign and give informed consent
  • Confirmed H. pylori infection and with previous treatment failure

Exclusion criteria

  • Less than 18 years old or older than 80 years
  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs
  • Administration of antibiotics, bismuth,antisecretory drugs in 8 weeks prior to inclusion

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

306 participants in 2 patient groups

Dual therapy
Active Comparator group
Description:
Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days
Treatment:
Drug: Esomeprazole
Drug: Amoxicillin
Metronidazole plus dual therapy
Experimental group
Description:
Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Treatment:
Drug: Esomeprazole
Drug: Metronidazole
Drug: Amoxicillin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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