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Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown
Phase 4

Conditions

Helicobacter Pylori Infection
Intravenous Drug Usage

Treatments

Drug: Esomeprazole
Drug: Metronidazole
Drug: Levofloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT04432233
rjkls2020031

Details and patient eligibility

About

Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female aged between 18 and 75 years old
  • Without previous Helicobacter pylori treatment
  • Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
  • Ability and willingness to participate in the study and to sign and give informed consent
  • Positive for Helicobacter pylori IgM antibody

Exclusion criteria

  • With previous gastric surgery
  • Major systemic diseases
  • Pregnancy or lactation
  • Allergy to any of the study drugs
  • Decline to participate in the study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Intravenous therapy
Experimental group
Description:
Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.
Treatment:
Drug: Metronidazole
Drug: Levofloxacin
Drug: Esomeprazole

Trial contacts and locations

1

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Central trial contact

Xiao Liang, PHD,MD

Data sourced from clinicaltrials.gov

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