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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Dyspeptic Subjects

Treatments: Drug: 13C-uracil; Drug: 99mTc sulfur colloid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01677338

URA-12-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

13C-uracil and 99mTc sulfur colloid

Experimental group

Description:

Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.

Treatment:

Drug: 99mTc sulfur colloid

Drug: 13C-uracil

99mTc sulfur colloid

Experimental group

Description:

Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid.

Treatment:

Drug: 99mTc sulfur colloid