POCone-UBiT-IR300 Pediatric Comparison Study

NCT01623154 | Completed Phase 4 Results

• 1 other identifier: UBT-1l-202
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 3

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.

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Keywords

Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Agreement Between POCone and UBiT-IR300.

  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).

  Baseline, Post Dose (15 min)

Other Outcomes (1)

• Number of Participants Tested Positive/Negative for H. Pylori

  Single Study Visit (1 hour of testing)

Study Arms (1)

BreathTek UBT

OTHER

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

Interventions

Pranactin citric solution OTHER

All patients were required to drink the pranactic citric solution to diagnose H.pylori.

BreathTek UBT

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Otsuka America Pharmaceutical: lead

Study Sites (3)

Miami Pediatric Gastroenterology

Miami, Florida, 33155, United States

Location

University of Texas School of Public Health

El Paso, Texas, 79902, United States

Location

Baylor College of Medicine

Houston, Texas, 77054, United States

Location

Results Point of Contact

• Title: Tao Wang, PhD
• Organization: Otsuka America Pharmaceutical, Inc

Tao.Wang@otsuka-us.com

240-683-3213

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 23, 2015
• Results First Posted: January 13, 2015

Record last verified: 2015-01

Locations

US (3)