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

This study has been completed.
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT00825630
First received: January 19, 2009
Last updated: February 15, 2012
Last verified: February 2012
Results First Received: June 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Helicobacter Pylori Infection
Interventions: Drug: Lansoprazole (Lanton)
Drug: Omeprezole (Losec)
Drug: Pantoprazole(Controloc)
Drug: Esomeprazole (Nexium)

  Participant Flow
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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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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  


Results Point of Contact:  
Name/Title: Dr. Haim Shirin
Organization: Sharon Hospital
phone: 0097239372231
e-mail: haims3@clalit.org.il


Publications of Results:

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT00825630     History of Changes
Other Study ID Numbers: HP-BID 608
Study First Received: January 19, 2009
Results First Received: June 19, 2011
Last Updated: February 15, 2012
Health Authority: Israel: Ministry of Health