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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01677338
First Posted: September 3, 2012
Last Update Posted: June 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Covance
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
  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 Drug: 99mTc sulfur colloid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Expired 13CO2 concentrations [ Time Frame: 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 Outcome Measures:
  • Concentrations of 13C-uracil and its major metabolites in plasma and urine [ Time Frame: 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


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
PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
Other Name: C13-URA
Drug: 99mTc sulfur colloid
PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.
Other Name: 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 Name: 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

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01677338     History of Changes
Other Study ID Numbers: URA-12-001
First Submitted: August 28, 2012
First Posted: September 3, 2012
Last Update Posted: June 2, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Technetium Tc 99m Sulfur Colloid
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action