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13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825630
First Posted: January 21, 2009
Last Update Posted: February 16, 2012
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.
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
Results First Submitted: June 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Helicobacter Pylori Infection
Interventions: Drug: Lansoprazole (Lanton)
Drug: Omeprezole (Losec)
Drug: Pantoprazole(Controloc)
Drug: Esomeprazole (Nexium)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Two out-patient clinics in hospitals will enroll subjects

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Size of arms varied due availability of PPI (proton pump inhibitors) and desire to gather more data in most common PPIs.Ethics committees approved additional recruitment.

Reporting Groups
  Description
Lansoprazole (Lanton) Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
Omeprazole( Losec) Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
Pantoprazole (Controloc) Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
Esomeprazole (Nexium) Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days

Participant Flow:   Overall Study
    Lansoprazole (Lanton)   Omeprazole( Losec)   Pantoprazole (Controloc)   Esomeprazole (Nexium)
STARTED   29   62   19   13 
COMPLETED   29   62   19   13 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.   [ Time Frame: 17 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It was hard to get people to agree to return for multiple tests within a few days, so the enrollment was difficult


  More Information