Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects

Completed · Phase 2

Conditions studied: Dyspeptic Subjects

In brief

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.

Key facts

Study ID

NCT01677338

Run by

Otsuka Pharmaceutical Co., Ltd.

People needed

20

Starts

2013-07-01

Expected to finish

2014-07-01

Last updated by the study team

2019-04-08

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body mass index [range is 18.0 to 33.0 kg/m2
• Subjects with any upper GI symptoms
• Stable creatinine

You may not qualify if…

• 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

Where it is running

• Compass Research — Orlando, Florida, United States
• Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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