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NCT04557189 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
NCT04557189: Completed Phase 2 study, sponsored by Takeda.
NCT04557189 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 89 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04557189, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
Study Summary
Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery. The main aim of this study is to learn if TAK-951 stops these adults from getting nausea or vomiting after surgery. This will be compared with another medicine called ondansetron. Another aim is to check for side effects from the study medicines. Before surgery, the study doctor will check who can take part in this study. Those who can take part will be picked for either Treatment Group A or Treatment Group B by chance. * Treatment Group A: Just before surgery, participants will receive a placebo slowly through a vein (infusion). Just before the end of the surgery, they will receive TAK-951 as an injection under the skin. * Treatment Group B: Just before surgery, participants will receive ondansetron slowly through a vein (infusion). Just before the end of the surgery, they will receive a placebo as an injection under the skin. In this study, a placebo will look like TAK-951 but will not have any medicine in it. Participants will not know which study medicines they received, or in which order, nor will their study doctors or surgeons. This is to help make sure the results are more reliable. Participants will stay in the hospital for 24 hours after their surgery so that the study doctors can check for nausea and vomiting. The study doctors will also check for side effects from the study medicines. Participants will visit the hospital for a check-up 14 days later.
Primary Outcome
Percentage of participants with complete response, defined as no emesis (vomiting or retching) and no need for rescue therapy (indicated if vomiting/retching and/or nausea score ≥4 or upon participant's request) were reported. The severity of nausea was scored using a self-reported, 11-point numerical Verbal Rating Scale (VRS), where 0 represents no nausea and 10 represents the worst nausea possible. Significant nausea was defined as a VRS score ≥4. Percentages are rounded off to whole number at
Interventions
- DRUG Ondansetron
- DRUG TAK-951
- DRUG Ondansetron Placebo
- DRUG TAK-951 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 2 |
What the finished NCT04557189 record still lists
NCT04557189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.
NCT04557189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04557189 about?
NCT04557189 is a clinical study titled "A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery". Some adults are at a higher risk of feeling sick (nausea) or being sick (vomiting) after they have surgery. In this study, these adults will have planned surgery. The main aim of this study is to learn if TAK-951 stops these adults from getting nausea or vomiting after surgery. This will be compared...
What is the current status of trial NCT04557189?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2020-10-20. Estimated completion is 2022-03-21.
What interventions are being tested in trial NCT04557189?
The interventions under investigation include: Ondansetron (DRUG), TAK-951 (DRUG), Ondansetron Placebo (DRUG), TAK-951 Placebo (DRUG).
Who is sponsoring clinical trial NCT04557189?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04557189's enrollment target sits among peer trials
89 802nd of 2000 higher than 1,198 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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