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

This study has been completed.
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: July 5, 2015
Last verified: July 2015

October 30, 2011
July 5, 2015
November 2011
December 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01481844 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection
Not Provided
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 .

a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. In sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . In quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up.

Compliance to the treatment was significant better in sequential group comparative to quadruple .Sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group.

The H pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication.

Sequential therapy showed the same eradication rate as second line treatment of H pylori as quadruple one, but was associated with better compliance and less adverse effects.

Both treatments protocols failed to show an appropriate eradication rate in population of Southern Israel .

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Optimization of Second Line Treatment Protocol for H Pylori Eradication
  • 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
  • Drug: Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
    this combination is standard of care as H pylori second line treatment
  • 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 )
    Intervention: Drug: Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole
  • Active Comparator: quadruple 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
    Intervention: Drug: Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01481844
sor006811ctil
Yes
Not Provided
Not Provided
Daniela Munteanu,MD ,Principal Investigator, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Daniela Munteanu, MD Soroka UMC
Soroka University Medical Center
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP