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TAK-951 for Postoperative Nausea and Vomiting

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to day 2)
Awards & highlights

Study Summary

A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery

Eligible Conditions
  • Postoperative Nausea and Vomiting

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to day 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to day 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Complete Response in the Immediate Postoperative Period
Secondary outcome measures
Peak Nausea Verbal Rating Scale (VRS) Score
Percentage of Participants Requiring Rescue Therapy for Breakthrough PONV Within 24 Hours Post-Surgery
Percentage of Participants With Absence of Nausea in the First 24 Hours Post-Surgery
+12 more

Side effects data

From 2022 Phase 2 trial • 89 Patients • NCT04557189
56%
Sinus tachycardia
39%
Hypotension
33%
Procedural hypotension
22%
Tachypnoea
17%
Tachycardia
11%
Hypertension
6%
Flatulence
6%
Decreased appetite
6%
Pruritus
6%
Gastrooesophageal reflux disease
6%
Hypokalaemia
6%
Anxiety
6%
Hypomagnesaemia
6%
Non-cardiac chest pain
6%
Blood pressure increased
6%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-951 Redacted mg SC
Ondansetron 4 mg IV
TAK-951 4 mg SC

Trial Design

2Treatment groups
Experimental Treatment
Group I: TAK-951 4 mg SCExperimental Treatment2 Interventions
Participants received prophylaxis with ondansetron placebo IV immediately before induction and TAK 951 4 mg, SC, approximately 30 to 45 minutes before the end of surgery (wound closure).
Group II: Ondansetron 4 mg IVExperimental Treatment2 Interventions
Participants received prophylaxis with ondansetron 4 mg, intravenously (IV) immediately before induction and TAK-951 placebo subcutaneously (SC) approximately 30 to 45 minutes before the end of surgery (wound closure).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-951
2019
Completed Phase 2
~250
Ondansetron Placebo
2012
Completed Phase 4
~1600
Ondansetron
2011
Completed Phase 4
~4010
TAK-951 Placebo
2019
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,927 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,210 Previous Clinical Trials
489,400 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,063,799 Total Patients Enrolled
1 Trials studying Postoperative Nausea and Vomiting
229 Patients Enrolled for Postoperative Nausea and Vomiting

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
2020. "A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04557189.
~20 spots leftby Apr 2025
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