Helicobacter Pylori Gastrointestinal Tract Infection Clinical Trial
Official title:
Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
NCT number | NCT03021590 |
Other study ID # | G5-17 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | January 31, 2022 |
Verified date | December 2018 |
Source | Damascus Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: -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, Tinidazole , 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. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Damascus Hospital | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus Hospital |
Syrian Arab Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Helicobacter pylori Eradication rate | Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis | 6 weeks after eradication therapy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02693574 -
Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori
|
Phase 4 |