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Status unknownNCT04626193Updated Nov 12, 2020

LOAD VS Levofloxacine Concomitant

A Phase 4 interventional study of Doxycycline and Levofloxacin 500mg in Helicobacter Pylori Infection, sponsored by Damascus Hospital. Status unknown at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-12.

Sponsored by Damascus Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • Doxycycline
  • LOAD regimen
  • Helicobacter Pylori
  • levofloxacine
  • tinadizole
03

In context

Lead sponsor

Damascus Hospital is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Doxycyclien

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

    Drug: Doxycycline

  • Active comparator
    Levofloxacine

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

    Drug: Levofloxacin 500mg

Interventions

  • DrugDoxycycline

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

    Also known as: Tinadizole, Esomeprazole, levofloxacine

  • DrugLevofloxacin 500mg

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

    Also known as: Amoxicilline, Esomeprazol, Tinadizole

06

What researchers measure

Primary outcomes

  1. Eradication rate of Helicobacter pylori infection

    Eradication rate of Helicobacter infected patients

    Time frame: 8 week from begning of treatment

07

Study locations

1 of 1 sites recruiting
  • General Assembly of Damascus Hospital
    Damascus, Syrian Arab Republic
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04626193
Lead sponsor
Damascus Hospital
Responsible party
Marouf Alhalabi (head of digestive diseases department, Damascus Hospital) — Principal investigator
First posted
Nov 12, 2020
Start date
Oct 31, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
May 30, 2024 (estimated)
Last update
Nov 12, 2020

Study contacts

Marouf MH Alhalabi, MD
Contact
e.marouf@hotmail.com
+963952781278
Marouf M Alhalabi, MD
principal investigator · general assambly of damascus hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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