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

This study is currently recruiting participants.
Verified July 2013 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01677338
First received: August 28, 2012
Last updated: August 5, 2013
Last verified: July 2013
  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 (accelerated or 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, Accelerated, 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


Estimated Enrollment: 36
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated 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 3 groups (with normal gastric emptying, with rapid (accelerated) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677338

Locations
United States, Florida
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Michael E Dever, M.D.    407-426-9299    drdever@compassresearch.com   
Contact: Judith A Chalykoff, M.D.    (407) 426-9299      
Principal Investigator: Michael E Dever, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Brian E Lacy, M.D.    603-650-5261    Brian.E.Lacy@hitchcock.org   
Contact: Alan H Siegel, M.D.    (603) 650-5261      
Principal Investigator: Brian E Lacy, MD, PhD         
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: August 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014