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WithdrawnNCT03021590Updated Dec 7, 2018

Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

A Phase 4 interventional study of Clarithromycin 500Mg Oral Tablet and Levofloxacin 500Mg Oral Tablet in Helicobacter Pylori Gastrointestinal Tract Infection, sponsored by Damascus Hospital. Withdrawn at 1 site in Syria. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-07.

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

Why this study was withdrawn
No Participants Enrolled
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population

02

Conditions studied

  • Helicobacter Pylori Gastrointestinal Tract Infection

Keywords

  • Helicobacter pylori
  • Helicobacter Infections
  • Proton Pump Inhibitors
  • sequential therapy
  • Clarithromycin
  • Tinidazole
03

In context

Helicobacter Infections

188 studies on the registry are indexed under Helicobacter Infections; 33 are open to participants now.

Browse Helicobacter Infections studies →

Lead sponsor

Damascus Hospital is the lead sponsor of 8 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 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Clarithromycin :Concomitant Therapy

    Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth

    Drug: Clarithromycin 500Mg Oral Tablet

  • Active comparator
    Levofloxacin :Concomitant Therapy

    Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth

    Drug: Levofloxacin 500Mg Oral Tablet

Interventions

  • DrugClarithromycin 500Mg Oral Tablet

    Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all ,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth

    Also known as: Esomeprazole 40Mg Capsule, Amoxicillin 1000Mg Capsule, Tinidazole 500Mg Tablet

  • DrugLevofloxacin 500Mg Oral Tablet

    Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth

    Also known as: Esomeprazole 40Mg Capsule, Amoxicillin 1000Mg Capsule, Tinidazole 500Mg Tablet

06

What researchers measure

Primary outcomes

  1. Helicobacter pylori Eradication rate

    Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis

    Time frame: 6 weeks after eradication therapy

07

Study locations

1 site
  • Damascus Hospital
    Damascus, +963, Syria
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2017 (actual). Primary completion is estimated for Dec 2021, 54 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2017
First posted
Jan 16, 2017
StartActual
Jun 1, 2017
Primary completionEst.
Dec 31, 2021
CompletionEst.
Jan 31, 2022
Last update
Dec 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03021590
Lead sponsor
Damascus Hospital
Responsible party
Sponsor
First posted
Jan 16, 2017
Start date
Jun 1, 2017
Primary completion
Dec 31, 2021 (estimated)
Completion
Jan 31, 2022 (estimated)
Last update
Dec 7, 2018

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Clarithromycin

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