Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori

March 18, 2017 updated by: Damascus Hospital

Comparison Efficacy of 14-day Triple Therapy Between Clarithromycin and Levofloxacin on the Eradication of Helicobacter Pylori in Syrian Population

Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the Eradication of Helicobacter Pylori in Syrian population

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1-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:

  1. Children and teenagers aged less than 18 years.
  2. Previous eradication treatment for H. pylori.
  3. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
  4. History of gastrectomy.
  5. Gastric malignancy, including adenocarcinoma and lymphoma,
  6. Previous allergic reaction to antibiotics (Amoxicillin, Clarithromycin, Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
  7. Contraindication to treatment drugs.
  8. Pregnant or lactating women.
  9. Severe concurrent disease.
  10. Liver cirrhosis.
  11. Chronic kidney disease.
  12. Patients who cannot give informed consent by himself or herself.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clarithromycin
Clarithromycin 500 mg Tablets and Esomeprazole 20 mg Capsule And Amoxicillin 1000 mg,Tablets by mouth every 12 hours for 14 days
Drug: Clarithromycin
Other Names:
  • Amoxicillin
  • Esomeprazole
Experimental: Levofloxacin
Levofloxacin 500 mg coated tablets and Esomeprazole 20 mg Capsule and Amoxicillin 1000 mg Tablets by mouth every 12 hours for 14 days
Drug: Levofloxacin
Other Names:
  • Amoxicillin
  • Esomeprazole,Amoxicillin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
Time Frame: 6 weeks after eradication therapy
6 weeks after eradication therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus Hospital

Collaborators

UNIPHARMA. Universal Pharmaceutical Industries
Ibn Alhaytham Pharma. Industries Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

January 28, 2017

Study Completion (Anticipated)

May 31, 2017

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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