Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic… (NCT01677338) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
United States20 participantsStarted 2013-07
Plain-language summary
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.
Who can participate
Age range21 Years – 65 Years
SexALL
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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