NCT04626193

Brief Summary

Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

November 8, 2020

Last Update Submit

November 8, 2020

Conditions

Helicobacter Pylori Infection

Keywords

DoxycyclineLOAD regimenHelicobacter Pylorilevofloxacinetinadizole

Outcome Measures

Primary Outcomes (1)

  • Eradication rate of Helicobacter pylori infection

    Eradication rate of Helicobacter infected patients

    8 week from begning of treatment

Study Arms (2)

Doxycyclien

EXPERIMENTAL

Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole

Drug: Doxycycline

Levofloxacine

ACTIVE COMPARATOR

Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline

Drug: Levofloxacin 500mg

Interventions

DoxycyclineDRUG

Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid

Also known as: Tinadizole, Esomeprazole, levofloxacine
Doxycyclien
Levofloxacin 500mgDRUG

Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Also known as: Amoxicilline, Esomeprazol, Tinadizole
Levofloxacine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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:
  • 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.

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, Tinadizole,
  • Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
  • Contraindication to treatment drugs.
  • Pregnant or lactating women.
  • Severe concurrent disease.
  • Liver cirrhosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Assembly of Damascus Hospital

Damascus, Syria

RECRUITING

MeSH Terms

Interventions

DoxycyclineEsomeprazoleOfloxacinLevofloxacinAmoxicillinOmeprazole

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFluoroquinolones4-QuinolonesQuinolonesQuinolinesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Marouf M Alhalabi, MD

    general assambly of damascus hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marouf MH Alhalabi, MD

CONTACT

+963952781278e.marouf@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of digestive diseases department

Study Record Dates

First Submitted

November 8, 2020

First Posted

November 12, 2020

Study Start

October 31, 2020

Primary Completion

December 31, 2023

Study Completion

May 30, 2024

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Within 5 year of study completion

Locations

SY(1)