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POCone-UBiT-IR300 Pediatric Comparison Study

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.
 
ClinicalTrials.gov Identifier: NCT01623154
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : January 13, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka America Pharmaceutical

Brief Summary:
The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring 13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in pediatric subjects.

Condition or disease Intervention/treatment Phase
Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Other: Pranactin citric solution Phase 4

Detailed Description:
The same patients will be tested on both the POCone® and UBiT®-IR300. If the patients test positive for H. pylori, they will be given eradication medication and brought back in for a re-test.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective, Multi-Center, Open-Label Study to Compare the POCone® With the UBiT®-IR300 in Measurement of 13CO2/12CO2 Ratio in Breath Samples Collected From Pediatric Subjects Ages 3 to 17 Years With Upper Gastrointestinal Signs and Symptoms
Study Start Date : July 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
BreathTek UBT
Comparison of Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300
Other: Pranactin citric solution
All patients were required to drink the pranactic citric solution to diagnose H.pylori.




Primary Outcome Measures :
  1. Agreement Between POCone and UBiT-IR300. [ Time Frame: Baseline, Post Dose (15 min) ]

    The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300.

    Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled "A" "B" "C". Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result.

    DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight).



Other Outcome Measures:
  1. Number of Participants Tested Positive/Negative for H. Pylori [ Time Frame: Single Study Visit (1 hour of testing) ]

    Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement.

    UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori.




Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subject ages 3 to 1711/12 years.
  2. Subject with upper gastrointestinal signs and symptoms (e.g., abdominal pain/discomfort, bloating, nausea, or vomiting, etc.)
  3. Subject and/or parent/legal guardian is capable of giving assent or consent.
  4. Subject is able to complete the urea breath test by investigator's assessment.

Exclusion Criteria:

  1. Subject is hypersensitive to mannitol, citric acid and/or aspartame.
  2. Previous diagnosis of phenylketonuria (PKU.
  3. Subject with difficulty swallowing or who may be at high risk for aspiration due to medical or physical conditions.
  4. Subjects with ongoing respiratory conditions or on bronchodilators that may compromise the collection of breath samples.
  5. Subjects with severe chronic illness (e.g., Crohn's disease, leukemia, kidney diseases, etc.)
  6. Administration of bismuth preparations (e.g., Pepto-Bismol®) at anytime within 14 days prior to the testing.
  7. Administration of antibiotics (e.g., amoxicillin, tetracycline, metronidazole, clarithromycin, azithromycin, etc.) therapy at anytime within 14 days prior to the testing.
  8. Administration of proton pump inhibitors (PPI; e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.) at anytime within 14 days prior to the testing.
  9. Administration of Histamine H2 receptor antagonist (H2RA; e.g., ranitidine, cimetidine, famotidine, nizatidine, etc.) at anytime within 24 hours prior to the testing.
  10. Treatment for eradication of H pylori within 28 days before testing or retesting.
  11. Participation in a drug or device study within 30 days of testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623154


Locations
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United States, Florida
Miami Pediatric Gastroenterology
Miami, Florida, United States, 33155
United States, Texas
University of Texas School of Public Health
El Paso, Texas, United States, 79902
Baylor College of Medicine
Houston, Texas, United States, 77054
Sponsors and Collaborators
Otsuka America Pharmaceutical

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Responsible Party: Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier: NCT01623154    
Other Study ID Numbers: UBT-1l-202
First Posted: June 19, 2012    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: February 23, 2015
Last Verified: January 2015
Keywords provided by Otsuka America Pharmaceutical:
Helicobacter pylori
Additional relevant MeSH terms:
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Bacterial Infections
Sodium Citrate
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action