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NCT01677338 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
A Phase 2 study, sponsored by Otsuka Pharmaceutical Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01677338: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Co..
NCT01677338 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Co.. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677338, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG 13C-uracil
- DRUG 99mTc sulfur colloid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01677338 record still lists
NCT01677338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which 13C-uracil is the first listed.
NCT01677338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01677338 about?
NCT01677338 is a clinical study titled "Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit 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.
What is the current status of trial NCT01677338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-07. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01677338?
The interventions under investigation include: 13C-uracil (DRUG), 99mTc sulfur colloid (DRUG).
Who is sponsoring clinical trial NCT01677338?
This trial is sponsored by Otsuka Pharmaceutical Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01677338's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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