Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Multi-center, Open-label Comparison Study of a 13C-uracil Breath Test Versus 99mTechnetium Sulfur Colloid Gastric Emptying Scintigraphy to Evaluate Normal, and Delayed Gastric Emptying Time in Dyspeptic Subjects|
- Expired 13CO2 concentrations [ Time Frame: 6 hours ] [ Designated as safety issue: No ]Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)[B] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2[B] semi solid: half emptying time of semi-solid test meal , and tlag[B] semi-solid: lag time of semi-solid test meal.
- Concentrations of 13C-uracil and its major metabolites in plasma and urine [ Time Frame: 6 hours ] [ Designated as safety issue: No ]PK parameters of 13C-uracil and its major metabolites, DHU and UPA, including AUCt, AUC∞, Cmax, tmax, λz, and t1/2,z, will be calculated based on plasma and urine concentration for 13C-uracil and its metabolites, and expired 13CO2-excretion, which calculated based on expired 13CO2 concentrations
|Study Start Date:||July 2013|
|Study Completion Date:||July 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: 13C-uracil and 99mTc sulfur colloid
Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.
Drug: 13C-uracil and 99mTc sulfur colloid
Visit 2: Day 15+-4, perform the Breath Test and Scintigraphy with Semi solid Test Meal containing 100 mg of 13C-uracil and 500 uCi
Other Name: C13-URA and Technetium Tc 99m Sulfur Colloid Injection
Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group.
The subjects will first have their gastric emptying rates investigated by scintigraphy using the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for evaluation of the 13C-uracil GEBT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677338
|United States, Florida|
|Orlando, Florida, United States, 32806|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology|
|Lebanon, New Hampshire, United States, 03756|
|Study Director:||Kimiyoshi Sudoh||Otsuka Pharmaceutical Co., Ltd.|