Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 21 - 65 |
Updated: | 4/21/2016 |
Start Date: | July 2013 |
End Date: | July 2014 |
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
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.
preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying
abnormal (delayed) gastric emptying rates in subjects.
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.
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.
Inclusion Criteria:
- Body mass index [range is 18.0 to 33.0 kg/m2
- Subjects with any upper GI symptoms
- Stable creatinine
Exclusion Criteria:
- History of known peptic ulcers or stomach cancer.
- History of stomach surgery or resection
- History of significant hypersensitivity, intolerance, or allergy to any drug
compound, food or other substance, unless approved by the investigator
- History of alcoholism or drug abuse
- History or presence of clinically significant GI, cardiovascular, central nervous
system, hepatic, or renal disease; or other conditions
- History of eating disorders
- History or presence of an abnormal ECG, which, in the opinion of the investigator, is
clinically significant
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