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

NCT02693574 | Unknown Phase 4 DMC

• 1 other identifier: G1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Gastrointestinal Tract Infection

Keywords

Helicobacter pylori; Helicobacter Infections; Proton Pump Inhibitors

Outcome Measures

Primary Outcomes (1)

• Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis

  6 weeks after eradication therapy

Study Arms (2)

Clarithromycin

ACTIVE COMPARATOR

Clarithromycin 500 mg Tablets and Esomeprazole 20 mg Capsule And Amoxicillin 1000 mg,Tablets by mouth every 12 hours for 14 days

Drug: Clarithromycin

Levofloxacin

EXPERIMENTAL

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

Interventions

Clarithromycin DRUG

Also known as: Esomeprazole, Amoxicillin

Clarithromycin

Levofloxacin DRUG

Also known as: Esomeprazole,Amoxicillin, Amoxicillin

Levofloxacin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus Hospital: lead
• UNIPHARMA. Universal Pharmaceutical Industries: collaborator
• Ibn Alhaytham Pharma. Industries Co: collaborator

Study Sites (1)

Damascus Hospital

Damascus, +963, Syria

Location

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Clarithromycin; Esomeprazole; Amoxicillin; Levofloxacin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 26, 2016
• Study Start: December 1, 2015
• Primary Completion: January 28, 2017
• Study Completion: May 31, 2017
• Last Updated: March 21, 2017

Record last verified: 2017-01

Locations

SY (1)