Dyspeptic SubjectsPhase 2NCT01677338
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
A Phase 2 study testing 13C-uracil and 99mTc sulfur colloid in people with Dyspeptic Subjects, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Dyspeptic Subjects
- What is being tested?
- 13C-uracil and 99mTc sulfur colloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index [range is 18.0 to 33.0 kg/m2
- Subjects with any upper GI symptoms
- Stable creatinine
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology
Lebanon, New Hampshire, 03756
Compass Research
Orlando, Florida, 32806
About this study
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
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.
Read the 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.
- Conditions
- Dyspeptic Subjects
- Being tested
- 13C-uracil, 99mTc sulfur colloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-uracilDrug
Also called C13-URA
PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
99mTc sulfur colloidDrug
Also called Technetium Tc 99m Sulfur Colloid Injection
PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| 13C-uracil and 99mTc sulfur colloid | Experimental | Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil. Receives: Drug: 13C-uracil; Drug: 99mTc sulfur colloid |
| 99mTc sulfur colloid | Experimental | Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Receives: Drug: 99mTc sulfur colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (1)
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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspeptic SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Kimiyoshi Sudoh, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677338
- Sponsor's protocol ID
- URA-12-001
- Status last verified
- Apr 2019
- First submitted
- 28 Aug 2012
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01677338
- Acronym / sponsor ID
- URA-12-001
- Conditions
- Dyspeptic Subjects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13C-uracil and 99mTc sulfur colloid | Experimental | Drug: 13C-uracil, Drug: 99mTc sulfur colloidSubjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil. |
| 99mTc sulfur colloid | Experimental | Drug: 99mTc sulfur colloidSubjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index [range is 18.0 to 33.0 kg/m2
- Subjects with any upper GI symptoms
- Stable creatinine
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C-uracilAlso: C13-URAPO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test. | Drug | 13C-uracil and 99mTc sulfur colloid |
| 99mTc sulfur colloidAlso: Technetium Tc 99m Sulfur Colloid InjectionPO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy. | Drug | 13C-uracil and 99mTc sulfur colloid, 99mTc sulfur colloid |
Primary outcome
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.
1 secondary outcome
Concentrations of 13C-uracil and its major metabolites in plasma and urine
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimiyoshi Sudoh study director
Otsuka Pharmaceutical Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 13C-uracil and 99mTc sulfur colloid in people with Dyspeptic Subjects, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expired 13CO2 concentrations (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.