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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Collaborator: Covance
• Treatments: Technetium Tc 99m Sulfur Colloid

Criteria

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