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

This study has been completed.
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01677338
First received: August 28, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Dyspeptic Subjects
Drug: 13C-uracil and 99mTc sulfur colloid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Expired 13CO2 concentrations [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Concentrations of 13C-uracil and its major metabolites in plasma and urine [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 20
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 and 99mTc sulfur colloid
Visit 2: Day 15+-4, perform the Breath Test and Scintigraphy with Semi solid Test Meal containing 100 mg of 13C-uracil and 500 uCi
Other Name: C13-URA and Technetium Tc 99m Sulfur Colloid Injection

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677338

Locations
United States, Florida
Compass Research
Orlando, Florida, United States, 32806
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Covance
Investigators
Study Director: Kimiyoshi Sudoh Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01677338     History of Changes
Other Study ID Numbers: URA-12-001
Study First Received: August 28, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Technetium Tc 99m Sulfur Colloid
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 20, 2014