Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this trial is to compare the non-inferiority efficacy and safety of two different treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily (PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily (CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP infection. One month after finishing each treatment, C13-urea breath testing will be required to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance mutations in HP strains by fluorescence in situ hybridization (FISH).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asofarma de México S.A de C.V.
• Collaborators: Centro InmunoQ, Mexico City; Centro Médico ABC Observatorio, Mexico City; Hospital Ángeles Metropolitano, Mexico City; Hospital Ángeles, Clínica Londres, Mexico City; Torre Mayo, Metepec, State of Mexico
• Treatments: Clarithromycin; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

1. Male or female adult subjects who wish to participate after signing the informed consent.

2. Aged between 18 and 65 years.

3. HP infection diagnosed by endoscopic gastric biopsy.

4. Subjects who fulfill the following HP eradication criteria according to Maastricht 3 Consensus Report:

• Non ulcer dyspepsia with gastric biopsy positive for HP infection,

• Uncomplicated duodenal ulcer (without active bleeding, perforation or stenosis) with gastric biopsy positive for HP infection,

• Uncomplicated benign gastric ulcer (without active bleeding, perforation or stenosis) with gastric biopsy positive for HP infection,

• Chronic intake of NSAIDs with gastric biopsy positive for HP infection without active gastrointestinal bleeding.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Subjects who have previously received the PLA or CLA treatment.

3. Subjects who are diagnosed by endoscopy with upper gastrointestinal bleeding secondary to active peptic ulcer (gastric or duodenal) with injuries classified in any of the following stages of the Forrest Classification: I-a (Spurting hemorrhage), I-b (Oozing hemorrhage), II-a (Visible vessel) or II-b (Adherent clot).

4. Subjects who are diagnosed by endoscopy with upper gastrointestinal bleeding by erosive gastritis secondary to active NSAID with positive biopsy for HP infection and whose clinical conditions require hospitalization and / or blood transfusion.

5. Subjects with psychiatric disorders including eating disorders.

6. Subjects with chronic degenerative diseases including uncontrolled hepatic, renal or endocrine diseases (except diabetes controlled by oral hypoglycemic agents or controlled hypothyroidism), malabsorption or chronic diarrhea, history of seizures or epilepsy, gastric surgery or subjects with oncological diseases.

7. Subjects with previous allergic reactions to any of the treatment components:

Pantoprazole, Amoxicillin, Clarithromycin, Azithromycin or Levofloxacin.

8. Subjects with a history of photosensitivity or tendinitis secondary to quinolones intake.

9. Subjects who are taking any of the following medications:

• NSAIDS: Fenbufen

• ergot

• Oral anticoagulants

• Cyclosporine

• Digoxin