NCT01677338

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Dyspeptic Subjects

Interventions

Type	Name	Description
DRUG	13C-uracil	PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
DRUG	99mTc sulfur colloid	PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2012-09-03
• Last updated: 2019-04-08

Locations

2 sites across 1 country: United States