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Sequential Therapy Versus Quadriple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

This study is currently recruiting participants.
Verified June 2012 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Daniela Munteanu,MD ,Principal Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01481844
First received: October 30, 2011
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

The aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of PPI + amoxicillin followed by 5 days of PPI + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of PPI+ bismuth + metronidazole + tetracycline ) as second line treatment of H. pylori .


Condition Intervention Phase
H Pylori Treatment
 Drug: Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole
Drug: Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • The eradication rate after second line treatment based on sequential therapy comparative to eradication rate after second line therapy based on quadriple regimen [ Time Frame: 18 month ] [ Designated as safety issue: Yes ]
    H pylori eradication is defined as a negative C-urea breath test 4-16 weeks after completion of tratment.]. (C-urea breath test- Patients are fasted for 4 h before testing. No test meal will be given, and a pre-dose breath sample is obtained. 75 mg of 13C-urea powder dissolved in 50 mL of water is then administered orally, and a second breath sample is collected 30 minutes later. Collected samples are analyzed using an isotope ratio mass spectrometer).


Secondary Outcome Measures:
  • The secondary end points: Adverse effects of sequential and quadruple treatment [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    -Adverse effects -taste alteration , peripheral neuropathy, seizures, nausea, vomiting, diarrhea, abdominal pain, allergic reaction, photo sensibility-checked at clinical visit by direct question.

  • compliance with treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    compliance is considered to be satisfactory when drug intake exceeded 80 %( by pills count).


Estimated Enrollment: 256
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sequential treatment
1.drugs experimental-Sequential -PPI( Lansoprazole 30mg x2/day) + amoxicillin 1gx2/day for 5days, followed by 5 days of PPI(Lansoprazole 30mg x2/day) + ( Clarithromycin500mg x2/day and Tinidazole 500mg x2/day )
 Drug: Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole
use of Sequential therapy as second line treatment for eradication H pylori currently Sequential therapy is indicated as first line treatment for H pylori eradication
Active Comparator: quadriple therapy
Quadruple drug regimen (i.e.-14 days of PPI (Lansoprazole 30mg x2/day) + Bismuth Subsalicylate 525mg X4/day + Metronidazole 500mg x3/day + Tetracycline 500mg x4/day )-is standard of care as second line treatment in eradication of H pylori
 Drug: Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
this combination is standard of care as H pylori second line treatment

  Eligibility

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

Inclusion Criteria:

  1. signed informed consent
  2. age at least 18 years
  3. persisting H.pylori infection after at least one course of first-line standard triple therapy (Amoxycillin, Clarithromycin or Metronidazole based)

Exclusion Criteria:

  1. history of gastrectomy
  2. gastric malignancy, including adenocarcinoma and lymphoma
  3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors
  4. Active upper gastrointestinal bleeding within the previous 1 week
  5. contraindications to the treatment drugs
  6. Pregnant or lactating women
  7. Severe concurrent disease or malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481844

Locations
Israel
Soroca UMC Recruiting
Beer-Sheva, Israel
Contact: Daniela Munteanu, MD     97286400252     danielamu@clalit.org.il    
Principal Investigator: Daniela Munteanu, MD            
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Daniela Munteanu, MD Soroka UMC
  More Information

No publications provided

Responsible Party: Daniela Munteanu,MD ,Principal Investigator, MD, Principal investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01481844     History of Changes
Other Study ID Numbers: sor006811ctil
Study First Received: October 30, 2011
Last Updated: June 18, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
sequential therapy
second line treatment
H pylori

Additional relevant MeSH terms:
Tetracycline
Clarithromycin
Amoxicillin
Lansoprazole
Metronidazole
Tinidazole
Bismuth
Bismuth subsalicylate
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Antacids
Antidiarrheals
Gastrointestinal Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Alkylating Agents
Antitrichomonal Agents
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on May 23, 2013