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NCT01149369 · ClinicalTrials.gov registry record · Phase 2
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT01149369: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01149369 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01149369, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
Primary Outcome
The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \< 25 mm.
Interventions
- DRUG Placebo
- DRUG Aprepitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01149369 record still lists
NCT01149369 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01149369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01149369 about?
NCT01149369 is a clinical study titled "Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial". The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
What is the current status of trial NCT01149369?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2013-04. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01149369?
The interventions under investigation include: Placebo (DRUG), Aprepitant (DRUG).
Who is sponsoring clinical trial NCT01149369?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01149369's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 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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