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

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ClinicalTrials.gov Identifier: NCT02693574
Recruitment Status : Unknown
Verified January 2017 by Damascus Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 26, 2016
Last Update Posted : March 21, 2017
Sponsor:
Collaborators:
UNIPHARMA. Universal Pharmaceutical Industries
Ibn Alhaytham Pharma. Industries Co
Information provided by (Responsible Party):
Damascus Hospital

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Efficacy of 14-day Triple Therapy Between Clarithromycin and Levofloxacin on the Eradication of Helicobacter Pylori in Syrian Population
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : January 28, 2017
Estimated Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


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:
  • Esomeprazole
  • Amoxicillin

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:
  • Esomeprazole,Amoxicillin
  • Amoxicillin




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


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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:

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.

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): NCT02693574


Locations
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Syrian Arab Republic
Damascus Hospital
Damascus, Syrian Arab Republic, +963
Sponsors and Collaborators
Damascus Hospital
UNIPHARMA. Universal Pharmaceutical Industries
Ibn Alhaytham Pharma. Industries Co

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Responsible Party: Damascus Hospital
ClinicalTrials.gov Identifier: NCT02693574     History of Changes
Other Study ID Numbers: G1
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Damascus Hospital:
Helicobacter pylori
Helicobacter Infections
Proton Pump Inhibitors

Additional relevant MeSH terms:
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Clarithromycin
Amoxicillin
Levofloxacin
Ofloxacin
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