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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02693574
• Date of registration: 11/02/2016
• Prospective Registration: No
• Primary sponsor: Damascus Hospital
• Public title: Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori
• Scientific title: Comparison Efficacy of 14-day Triple Therapy Between Clarithromycin and Levofloxacin on the Eradication of Helicobacter Pylori in Syrian Population
• Date of first enrolment: December 1, 2015
• Target sample size: 74
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02693574
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Syrian Arab Republic

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Helicobacter Pylori Gastrointestinal Tract Infection

Intervention(s)

Drug: Levofloxacin

Drug: Clarithromycin

Primary Outcome(s)

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

Secondary ID(s)

G1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ibn Alhaytham Pharma. Industries Co

UNIPHARMA. Universal Pharmaceutical Industries