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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01131026
• Date of registration: 12/05/2010
• Prospective Registration: Yes
• Primary sponsor: Deva Holding A.S.
• Public title: Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication
• Scientific 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
• Date of first enrolment: June 2010
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01131026
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Turkey

Contacts

• Name: Recep S Alpan, MD, PhD, MSc
• Affiliation: TNC Pharmaceuticals Research, Development and Consultancy Ltd.

• Name: Mehmet Yucesoy, MD
• Affiliation: Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Helicobacter Pylori Infection

Intervention(s)

Drug: Amoxicillin

Drug: Levofloxacin

Drug: Lansoprazole

Primary Outcome(s)

Helicobacter pylori infection eradication [Time Frame: 6 weeks]

Secondary Outcome(s)

Safety [Time Frame: 6 weeks]

Secondary ID(s)

DV-09-0015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

TC Erciyes University