Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 21 for:    "Gastritis" | "Clarithromycin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02726269
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : April 4, 2016
Sponsor:
Collaborators:
Hospital Ángeles, Clínica Londres, Mexico City
Centro InmunoQ, Mexico City
Torre Mayo, Metepec, State of Mexico
Hospital Ángeles Metropolitano, Mexico City
Centro Médico ABC Observatorio, Mexico City
Information provided by (Responsible Party):
Asofarma de México S.A de C.V.

Brief 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).

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Gastritis Drug: CLA (Clarithro+Lanso+Amoxi) Drug: PLA (Panto+Levoflox+Azithro) Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication in Mexico With a Levofloxacin-containing Scheme Versus Clarithromycin-based Triple Therapy: a Randomized, Open-label, Non-inferiority, Phase 3b Trial.
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CLA (Clarithro+Lanso+Amoxi)
Clarithromycin 500 mg bid, Lansoprazole 30 mg bid and Amoxicillin 500 bid, tablets of oral administration, during 10 days.
Drug: CLA (Clarithro+Lanso+Amoxi)
Tablets of oral administration administered to subjects randomized to this group twice daily for 10 days.
Other Name: Pylopac®, Medix, Mexico

Experimental: PLA (Panto+Levoflox+Azithro)
Pantoprazole 80 mg od, Levofloxacin 500 mg od and Azithromycin 500 mg od, tablets of oral administration, during 10 days.
Drug: PLA (Panto+Levoflox+Azithro)
Tablets of oral administration to subjects randomized to this group once daily for 10 days.
Other Name: Zoltum®, Truxa® (MTV SA, Argentina), Levofloxacino, AsoMex




Primary Outcome Measures :
  1. HP eradication rate calculated from negative 13C-urea breath tests. [ Time Frame: Four weeks after the end of the allocated treatment. ]

Secondary Outcome Measures :
  1. Determine the frequency of Clarithromycin-resistance mutations by fluorescence in situ hybridization (FISH). [ Time Frame: Within a month after taking gastric endoscopy biopsy to confirm the diagnosis of HP infection. ]
  2. Compare the proportion of Clarithromycin-resistance mutations determined by FISH with the HP eradication rate calculated. [ Time Frame: A week after both proportions are calculated. ]

Other Outcome Measures:
  1. Percentage and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) in each group (PLA vs CLA). [ Time Frame: Up to a month after the end of both treatments. ]
  2. Proportion of treatments prematurely suspended due to AEs or SAEs in each group (PLA vs CLA). [ Time Frame: Within ten days after each treatment is randomly allocated. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726269


Sponsors and Collaborators
Asofarma de México S.A de C.V.
Hospital Ángeles, Clínica Londres, Mexico City
Centro InmunoQ, Mexico City
Torre Mayo, Metepec, State of Mexico
Hospital Ángeles Metropolitano, Mexico City
Centro Médico ABC Observatorio, Mexico City
Investigators
Layout table for investigator information
Principal Investigator: Alma L Ladrón de Guevara, MD

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Asofarma de México S.A de C.V.
ClinicalTrials.gov Identifier: NCT02726269     History of Changes
Other Study ID Numbers: ASO HO 01
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Asofarma de México S.A de C.V.:
Helicobacter Pylory infections
Levofloxacin
Antibiotic resistance
Clarithromycin
Mutations
Fluorescence
Hybridization

Additional relevant MeSH terms:
Layout table for MeSH terms
Gastritis
Clarithromycin
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors