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

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ClinicalTrials.gov Identifier: NCT00825630
Recruitment Status : Completed
First Posted : January 21, 2009
Results First Posted : October 7, 2011
Last Update Posted : February 16, 2012
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

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)
Enrollment 123
Recruitment Details Two out-patient clinics in hospitals will enroll subjects
Pre-assignment Details 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.
Arm/Group Title Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium)
Hide Arm/Group Description Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
Period Title: Overall Study
Started 29 62 19 13
Completed 29 62 19 13
Not Completed 0 0 0 0
Arm/Group Title Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium) Total
Hide Arm/Group Description Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days Total of all reporting groups
Overall Number of Baseline Participants 29 62 19 13 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 62 participants 19 participants 13 participants 123 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  89.7%
55
  88.7%
17
  89.5%
9
  69.2%
107
  87.0%
>=65 years
3
  10.3%
7
  11.3%
2
  10.5%
4
  30.8%
16
  13.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 62 participants 19 participants 13 participants 123 participants
52.86  (14.67) 52.48  (13.35) 51.84  (12.78) 55.38  (14.84) 52.46  (14.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 62 participants 19 participants 13 participants 123 participants
Female
20
  69.0%
40
  64.5%
15
  78.9%
7
  53.8%
82
  66.7%
Male
9
  31.0%
22
  35.5%
4
  21.1%
6
  46.2%
41
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 29 participants 62 participants 19 participants 13 participants 123 participants
29 62 19 13 123
H. Pyori Positive   [1] 
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 29 participants 62 participants 19 participants 13 participants 123 participants
29 62 19 13 123
[1]
Measure Description: Basline particpants include all those with suspected H.pylori infection that are tested with the FDA cleared BreathID 13C urea breath test and are found to be positive, that is DOB (delta over baseline) >=5
1.Primary Outcome
Title Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
Hide Description Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.
Time Frame 17 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study.
Arm/Group Title Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium)
Hide Arm/Group Description:
Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
Overall Number of Participants Analyzed 29 62 19 13
Measure Type: Number
Unit of Measure: participants
False negatives (DOB<5) after 3 days of no PPI 1 3 1 0
False negatives (DOB<5) after 1 day of no PPI 2 4 2 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium)
Hide Arm/Group Description Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
All-Cause Mortality
Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/62 (0.00%)   0/19 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Lansoprazole (Lanton) Omeprazole( Losec) Pantoprazole (Controloc) Esomeprazole (Nexium)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/62 (0.00%)   0/19 (0.00%)   0/13 (0.00%) 
It was hard to get people to agree to return for multiple tests within a few days, so the enrollment was difficult
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.
Results Point of Contact
Name/Title: Dr. Haim Shirin
Organization: Sharon Hospital
Phone: 0097239372231
Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT00825630     History of Changes
Other Study ID Numbers: HP-BID 608
First Submitted: January 19, 2009
First Posted: January 21, 2009
Results First Submitted: June 19, 2011
Results First Posted: October 7, 2011
Last Update Posted: February 16, 2012