- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626193
LOAD VS Levofloxacine Concomitant
November 8, 2020 updated by: Marouf Alhalabi, Damascus Hospital
Comparing the Efficacy of Two Weeks Therapy of Doxycycline,Levofloxacin,Tinidazole Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population
Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marouf MH Alhalabi, MD
- Phone Number: +963952781278
- Email: e.marouf@hotmail.com
Study Locations
-
-
-
Damascus, Syrian Arab Republic
- Recruiting
- General Assembly of Damascus Hospital
-
Contact:
- Marouf MI Alhalabi, MD
- Phone Number: +963952781278
- Email: e.marouf@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
- Positive rapid urease test (CLOtest).
- Histologic evidence of H. pylori by modified Giemsa staining.
- 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, Tinadizole,
- Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
- Contraindication to treatment drugs.
- Pregnant or lactating women.
- Severe concurrent disease.
- Liver cirrhosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Doxycyclien
Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole
|
Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole
500 bid
Other Names:
|
Active Comparator: Levofloxacine
Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline
|
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eradication rate of Helicobacter pylori infection
Time Frame: 8 week from begning of treatment
|
Eradication rate of Helicobacter infected patients
|
8 week from begning of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marouf M Alhalabi, MD, general assambly of damascus hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
May 30, 2024
Study Registration Dates
First Submitted
November 8, 2020
First Submitted That Met QC Criteria
November 8, 2020
First Posted (Actual)
November 12, 2020
Study Record Updates
Last Update Posted (Actual)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 8, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antimalarials
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Doxycycline
- Amoxicillin
- Levofloxacin
- Ofloxacin
- Esomeprazole
Other Study ID Numbers
- G-10-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
Within 5 year of study completion
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Helicobacter Pylori Infection
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
The First Affiliated Hospital of Nanchang UniversityUnknownBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Eradication Therapy of Helicobacter Pylori | Detection of Helicobacter PyloriChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedHelicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)Helicobacter Pylori Infection | Helicobacter Pylori gyrA Levofloxacin Resistance Mutation | Fecal Drug Resistance Gene Detection | Helicobacter Pylori Infection, Susceptibility toChina
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
-
Kaohsiung Veterans General Hospital.Kaohsiung Medical University Chung-Ho Memorial HospitalCompletedHelicobacter Pylori InfectionTaiwan
Clinical Trials on Doxycycline
-
Thomas GardnerJuvenile Diabetes Research FoundationCompleted
-
University of PittsburghTu Du HospitalCompleted
-
Par Pharmaceutical, Inc.AnapharmCompletedTo Determine Bioequivalence Under Fed ConditionsCanada
-
Warner ChilcottCompletedAcne VulgarisUnited States
-
PfizerCompleted
-
Warner ChilcottCompleted
-
Samsung Medical CenterCompleted
-
Chinese University of Hong KongNot yet recruitingChlamydia | Gonorrhea | Sexually Transmitted Diseases, Bacterial | SyphilisHong Kong
-
University Medical Centre LjubljanaUniversity of Ljubljana School of Medicine, SloveniaCompleted
-
Aljazeera HospitalUnknown