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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01677338

Enrollment

Registered

2012-09-03

Start date

2013-07-31

Completion date

2014-07-31

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspeptic Subjects

Brief 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.

Interventions

DRUG13C-uracil

PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.

DRUG99mTc sulfur colloid

PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Expired 13CO2 concentrations	6 hours	Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)\[B\] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2\[B\] semi solid: half emptying time of semi-solid test meal , and tlag\[B\] semi-solid: lag time of semi-solid test meal.

Secondary

Measure	Time frame	Description
Concentrations of 13C-uracil and its major metabolites in plasma and urine	6 hours	PK parameters of 13C-uracil and its major metabolites, DHU and UPA, including AUCt, AUC∞, Cmax, tmax, λz, and t1/2,z, will be calculated based on plasma and urine concentration for 13C-uracil and its metabolites, and expired 13CO2-excretion, which calculated based on expired 13CO2 concentrations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026