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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Soroka University Medical Center.
Recruitment status was  Recruiting
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
  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:


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
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, see Learn About Clinical Studies.

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:
Amoxicillin
Clarithromycin
Tetracycline
Metronidazole
Tinidazole
Lansoprazole
Dexlansoprazole
Bismuth subsalicylate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Alkylating Agents
Antitrichomonal Agents
Antidiarrheals

ClinicalTrials.gov processed this record on September 18, 2014