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

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.

Study Overview

• Status: Completed
• Conditions: Dyspeptic Subjects
• Intervention / Treatment: Drug: 13C-uracil; Drug: 99mTc sulfur colloid

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13C-uracil and 99mTc sulfur colloid; Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.	Drug: 13C-uracil; PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.; Other Names: C13-URA; Drug: 99mTc sulfur colloid; PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.; Other Names: Technetium Tc 99m Sulfur Colloid Injection
Experimental: 99mTc sulfur colloid; Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid.	Drug: 99mTc sulfur colloid; PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.; Other Names: Technetium Tc 99m Sulfur Colloid Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expired 13CO2 concentrations	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.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of 13C-uracil and its major metabolites in plasma and urine	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	6 hours

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Collaborators: Covance
• Investigators: Study Director: Kimiyoshi Sudoh, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sulfur Colloid
• Other Study ID Numbers: URA-12-001