NCT04348786

Brief Summary

Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

January 29, 2020

Last Update Submit

September 15, 2020

Conditions

Helicobacter Pylori Infection

Keywords

DoxycyclienBismuth SubsalicylateHelicobacter 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 and bismuth subsalicylate

Drug: Doxycycline

Levofloxacine

ACTIVE COMPARATOR

Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole

Drug: Levofloxacin 500mg

Interventions

DoxycyclineDRUG

Doxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid

Also known as: Tinadizole, Esomeprazole, Bismuth subsalicylate
Doxycyclien
Levofloxacin 500mgDRUG

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

Also known as: Amoxicilline, Esomeprazol, Tinadiole
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

Location

Related Publications (1)

  • Alhalabi M, Alassi MW, Alaa Eddin K, Cheha K. Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial. BMC Infect Dis. 2021 Jul 4;21(1):642. doi: 10.1186/s12879-021-06356-5.

    PMID: 34218802DERIVED

MeSH Terms

Interventions

DoxycyclineEsomeprazolebismuth subsalicylateLevofloxacinAmoxicillinOmeprazole

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Marouf M Alhalabi, MD

    general assambly of damascus hospital

    PRINCIPAL INVESTIGATOR

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

January 29, 2020

First Posted

April 16, 2020

Study Start

February 1, 2019

Primary Completion

August 30, 2020

Study Completion

September 1, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

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

Locations

SY(1)