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

Sponsor

Damascus Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02693574

Collaborator

UNIPHARMA. Universal Pharmaceutical Industries (Other), Ibn Alhaytham Pharma. Industries Co (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2015

Actual Primary Completion Date :

Jan 28, 2017

Anticipated Study Completion Date :

May 31, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis [6 weeks after eradication therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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, Clarithromycin, 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.