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Completed

NCT Number: NCT04348786

Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori

Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Assembly of Damascus Hospital

Damascus, Syria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
  • Positive rapid urease test (CLOtest).
  • Histologic evidence of H. pylori by modified Giemsa staining.
  • Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion criteria

  • Children and teenagers aged less than 18 years.
  • Previous eradication treatment for H. pylori.
  • Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
  • History of gastrectomy.
  • Gastric malignancy, including adenocarcinoma and lymphoma,
  • Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
  • Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
  • Contraindication to treatment drugs.
  • Pregnant or lactating women.
  • Severe concurrent disease.
  • Liver cirrhosis.

Treatment and study plan

Doxycycline

Drug

Doxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid

Other names: Tinadizole, Esomeprazole, Bismuth subsalicylate

Levofloxacin 500mg

Drug

Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Other names: Amoxicilline, Esomeprazol, Tinadiole

Primary outcomes

  1. Eradication rate of Helicobacter pylori infection

    Time frame: 8 week from begning of treatment

    Eradication rate of Helicobacter infected patients

Sponsors and collaborators

Lead sponsor

Damascus Hospital

Other

Registry information

Official study title

Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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