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

NCT01131026 | Completed Phase 3

• 1 other identifier: DV-09-0015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; levofloxacin; amoxicillin; lansoprazole; efficacy; safety; triple therapy

Outcome Measures

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.

  6 weeks

Secondary Outcomes (1)

• Safety

  6 weeks

Interventions

Levofloxacin DRUG

tablet, 500 mg, once a day for ten days

Also known as: Floxilevo 500 mg Tablet

Amoxicillin DRUG

tablet, 1000 mg, once a day for ten days

Also known as: Dentamax 1 gr Tablet

Lansoprazole DRUG

capsule, 30 mg, twice a day for ten days

Also known as: Degastrol 30 mg Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Deva Holding A.S.: lead
• TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti.: collaborator
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Levofloxacin; Tablets; Amoxicillin; Lansoprazole

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Mehmet Yucesoy, MD

  Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology

  PRINCIPAL INVESTIGATOR

• Recep S Alpan, MD, PhD, MSc

  TNC Pharmaceuticals Research, Development and Consultancy Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 26, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

TU (1)