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CompletedNCT01131026Updated Aug 9, 2011

Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

A Phase 3 interventional study of Levofloxacin and Amoxicillin in Helicobacter Pylori Infection, sponsored by Deva Holding A.S.. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-09.

Sponsored by Deva Holding A.S. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.

Read the detailed description

The primary end point in this study is appointed to be "Helicobacter pylori infection eradication with TRIOL treatment" and the secondary end point as "safety". The study involves the investigation of the efficacy and safety of the triple treatment consisting of 500 mg levofloxacin, 1000 mg amoxicillin and 30 mg lansoprazole on Helicobacter pylori eradication in 60 patients with Helicobacter pylori infection.

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • Helicobacter pylori
  • levofloxacin
  • amoxicillin
  • lansoprazole
  • efficacy
  • safety
  • triple therapy
03

In context

Lead sponsor

This is the only study on the registry with Deva Holding A.S. as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Consenting to an endoscopy
  • Signing the informed consent form
  • Not receiving Helicobacter pylori eradication treatment before
  • Showing Helicobacter pylori infection by rapid urease test and/or Giemsa staining
  • Being older than 18 years of age

Exclusion criteria

Exclusion Criteria:

  • Being younger than 18 years of age
  • Receiving H. pylori eradication treatment previously
  • Having gastrectomy or vagotomy in medical history
  • Having gastric malignancy, including adenocarcinoma and lymphoma
  • Having other severe malignant disease
  • Previously having allergic reaction to antibiotics (amoxicillin, levofloxacin) and proton pump inhibitors (lansoprazole)
  • Using prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the last 4 weeks
  • Having active upper GI bleeding in the last week
  • Being pregnant or lactating
  • Taking long term high dosages of aspirin, corticosteroid and other NSAIDs in the last 4 weeks
  • Taking any antibiotics or proton pump inhibitors other than the study medication during the study period
  • Taking antacids and/or H2-blockers during the study period
  • Taking bismuth compounds within four weeks prior to and during the study period
  • Having dysphasia or vomiting as major symptoms
  • Having psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study
  • Having severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system.
  • Having known uncontrolled hypertension
  • Being immunocompromised
  • Showing clinically significant abnormal vital signs
  • Having clinically significant abnormal ECG findings
  • Presenting clinically significant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety
  • Being exposed to any investigational drug within 30 days prior to screening
  • Having known hypersensitivity to or contraindication against fluoroquinolones.
  • Having current diagnosis or known history of substance abuse.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • DrugLevofloxacin

    tablet, 500 mg, once a day for ten days

    Also known as: Floxilevo 500 mg Tablet

  • DrugAmoxicillin

    tablet, 1000 mg, once a day for ten days

    Also known as: Dentamax 1 gr Tablet

  • DrugLansoprazole

    capsule, 30 mg, twice a day for ten days

    Also known as: Degastrol 30 mg Capsule

06

What researchers measure

Primary outcomes

  1. Helicobacter pylori infection eradication

    After 6 weeks from the end of the TRIOL treatment, demonstrating the ratio of patients who do not develop Helicobacter pylori infection by rapid urease test and Giemsa staining.

    Time frame: 6 weeks

Secondary outcomes

  1. Safety

    During the study all patients will be examined at the determined timepoints in the protocol in regard to any type of clinical adverse event. These examinations involve clinical and laboratory examinations of which the results will be recorded in the final study report and discussed with respect to the current literature.

    Time frame: 6 weeks

07

Study locations

1 site
  • Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology
    Kayseri, 38039, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01131026
Lead sponsor
Deva Holding A.S.
Collaborators
TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti., TC Erciyes University
First posted
May 26, 2010
Start date
Jun 2010
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Aug 9, 2011

Study contacts

Mehmet Yucesoy, MD
principal investigator · Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology
Recep S Alpan, MD, PhD, MSc
study director · TNC Pharmaceuticals Research, Development and Consultancy Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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