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

Sponsor
Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01677338
Collaborator
Covance (Industry)
20
Enrollment
2
Locations
2
Arms
12
Duration (Months)
10
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
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
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Compass Research Orlando Florida United States 32806
    2 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01677338
    Other Study ID Numbers:
    • URA-12-001
    First Posted:
    Sep 3, 2012
    Last Update Posted:
    Apr 8, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:
    Technetium Tc 99m Sulfur Colloid

    Study Results

    No Results Posted as of Apr 8, 2019