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Trial record 50 of 353 for:    clarithromycin

Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03021590
Recruitment Status : Withdrawn (No Participants Enrolled)
First Posted : January 16, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus Hospital

Brief Summary:
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Gastrointestinal Tract Infection Drug: Clarithromycin 500Mg Oral Tablet Drug: Levofloxacin 500Mg Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clarithromycin :Concomitant Therapy
Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth
Drug: Clarithromycin 500Mg Oral Tablet

Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all

,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth

Other Names:
  • Esomeprazole 40Mg Capsule
  • Amoxicillin 1000Mg Capsule
  • Tinidazole 500Mg Tablet

Active Comparator: Levofloxacin :Concomitant Therapy
Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth
Drug: Levofloxacin 500Mg Oral Tablet
Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth
Other Names:
  • Esomeprazole 40Mg Capsule
  • Amoxicillin 1000Mg Capsule
  • Tinidazole 500Mg Tablet




Primary Outcome Measures :
  1. Helicobacter pylori Eradication rate [ Time Frame: 6 weeks after eradication therapy ]
    Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-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, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
  • Contraindication to treatment drugs.
  • Pregnant or lactating women.
  • Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
  • Patients who cannot give informed consent by himself or herself.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021590


Locations
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Syrian Arab Republic
Damascus Hospital
Damascus, Syrian Arab Republic, +963
Sponsors and Collaborators
Damascus Hospital

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Responsible Party: Damascus Hospital
ClinicalTrials.gov Identifier: NCT03021590     History of Changes
Other Study ID Numbers: G5-17
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damascus Hospital:
Helicobacter pylori
Helicobacter Infections
Proton Pump Inhibitors
sequential therapy
Clarithromycin
Tinidazole

Additional relevant MeSH terms:
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Clarithromycin
Amoxicillin
Levofloxacin
Ofloxacin
Tinidazole
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Alkylating Agents
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents