Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication - Full Text View

Purpose

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.

Condition	Intervention	Phase
Helicobacter Pylori Infection	Drug: Levofloxacin Drug: Amoxicillin Drug: Lansoprazole	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Monocentric, Open-label, Efficacy and Safety Evaluation Study of the Triple Therapy of 500 mg Levofloxacin, 1000 mg Amoxicillin and 30 mg Lansoprazole on Helicobacter Pylori Eradication in 60 Patients Infected With H. Pylori

Resource links provided by NLM:

Drug Information available for: Amoxicillin Amoxicillin sodium Ofloxacin Levofloxacin Lansoprazole Ofloxacin hydrochloride Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Deva Holding A.S.:

Primary Outcome Measures:

Helicobacter pylori infection eradication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	60
Study Start Date:	June 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

tablet, 500 mg, once a day for ten days

Other Name: Floxilevo 500 mg Tablet

tablet, 1000 mg, once a day for ten days

Other Name: Dentamax 1 gr Tablet

capsule, 30 mg, twice a day for ten days

Other Name: Degastrol 30 mg Capsule

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131026

Locations

Turkey
Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology
Kayseri, Turkey, 38039

Sponsors and Collaborators

Deva Holding A.S.

TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti.

TC Erciyes University

Investigators

Principal Investigator:	Mehmet Yucesoy, MD	Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology
Study Director:	Recep S Alpan, MD, PhD, MSc	TNC Pharmaceuticals Research, Development and Consultancy Ltd.

More Information

No publications provided

Responsible Party:	Prof. Dr. R. Serdar Alpan, MD, PhD, MSc, TNC İlac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti.
ClinicalTrials.gov Identifier:	NCT01131026 History of Changes
Other Study ID Numbers:	DV-09-0015
Study First Received:	May 12, 2010
Last Updated:	August 8, 2011
Health Authority:	Turkey: Ministry of Health

Keywords provided by Deva Holding A.S.:

Helicobacter pylori
levofloxacin
amoxicillin
lansoprazole

efficacy
safety
triple therapy

Additional relevant MeSH terms:

Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Ofloxacin
Lansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 21, 2013