Postoperative Nausea and Vomiting (PONV)Phase 2NCT04557189
A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
A Phase 2 study testing TAK-951 and Ondansetron in people with Postoperative Nausea and Vomiting (PONV), run by Takeda at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- TAK-951 and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Oct 2020to 21 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants undergoing elective surgery under general anesthesia, expected to last for at least 1 hour from induction of anesthesia to wound closure.
- Participants are expected to require or have agreed to stay, at least 1 overnight in the hospital.
- Participants American Society of Anesthesiologists (ASA) physical status is ASA I-III.
- Participants with 3 or more Apfel risk factors defined as:
- Female sex.
- Nonsmoking status (never smoked or stopped smoking ≥12 months ago).
- History of PONV or motion sickness.
- Planned use of postoperative opioid analgesics.
Who cannot join
- Participants who are expected to remain intubated post-anesthesia.
- Participants who experience nausea or vomiting within 24 hours before surgery or are diagnosed with gastroparesis, cyclic vomiting syndrome, or other condition associated with acute or chronic nausea and vomiting.
- Participants who have received, or are expected to receive, any excluded drug preoperatively within 24 hours before induction, during surgery, or within 24 hours after surgery.
- Participants scheduled to receive neuraxial anesthesia (e.g., epidural, spinal, or caudal anesthesia), regional blocks, or total IV anesthesia, and/or planned to receive different drugs for premedication, induction, maintenance, or reversal of anesthesia than those specified in the protocol.
- Participants who have an allergy or contraindication to the recommended and available rescue therapy for the treatment of PONV.
- Circumstance that, in the investigator's opinion, make participation in this clinical study inappropriate.
Show all 14Show fewer
- Participants found at the screening to have a QT interval with Fridericia correction method (QTcF) ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events. Assessments showing bundle branch block and a prolonged QTcF should be discussed with the study monitor and the sponsor for potential inclusion.
- Participants who have a direct family history of premature sudden death or channelopathy, personal history of Brugada syndrome (right bundle branch block pattern with ST elevation in leads V1-V3), long QT, short QT, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy or catecholaminergic polymorphic ventricular tachycardia (VT).
- Participants who have had 3 incidents of vasovagal syncope within the last 5 years.
- Participants with an average heart rate (HR) <55 or >100 bpm or systolic blood pressure (SBP) <90 mm Hg or Diastolic blood pressure (DBP) <60 mm Hg during screening or prior to randomization on the day of surgery.
- Participants with a clinically significant ECG abnormality indicative of acute cardiac instability as determined by the investigator at screening, including more than first-degree atrioventricular block, nonsustained or sustained VT, or ECG changes consistent with acute myocardial ischemia or infarction.
- Participants with a history of acute myocardial ischemia within the last 12 months.
- Participants receiving beta-blockers chronically or between screening and surgery that cannot be safely withheld on the day of surgery in the investigator's judgment. Participants receiving certain other cardiovascular medications, such as vasodilators for hypertension, chronically or between screening and surgery that in the investigator's judgment cannot be adequately managed in the perioperative setting considering the potential vasodilatory effects of TAK-951 and anesthesia standard of care. The investigators must consult with the medical monitor regarding the eligibility of participants who are receiving beta-blockers, vasodilators, and other classes of medications that act on HR or BP.
- Participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
First Street Hospital - Research
Bellaire, Texas, 77401
Legent Orthopedic Hospital
Carrollton, Texas, 75006
Altus Houston Hospital - Hospital
Houston, Texas, 77072
Lotus Clinical Research Inc
Pasadena, California, 91105
Helen Keller Hospital
Sheffield, Alabama, 35660
Stony Brook Medicine - Hospital
Stony Brook, New York, 11794
Phoenix Clinical Research
Tamarac, Florida, 33321
About this study
Official title: A Randomized Double-Blind, Sponsor-Open, Double-Dummy, Proof of Concept Phase 2 Study to Evaluate the Efficacy and Safety of TAK-951 Versus Ondansetron in the Prophylaxis of Postoperative Nausea and Vomiting in High-Risk Subjects
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.
Read more
- 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.
Read the detailed description
The drug being tested in this study is called TAK-951. TAK-951 is being tested for prophylaxis for postoperative nausea and vomiting in high-risk participants.
The study will enroll a maximum of 160 patients, to allow a sample size of up to approximately 100 participants who have received both doses of Double-blind study drug/matching placebo. Participants will be randomly assigned in a 1:1 ratio to either Treatment Group A or Treatment Group B which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- 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.
This trial will be conducted in the United States. The overall time to participate in the study from the time of surgery to completion is approximately 14 days. Participants will make multiple visits to the clinic and will be contacted by telephone after receiving their last dose of the drug for a follow-up assessment.
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Being tested
- TAK-951, Ondansetron, Ondansetron Placebo, TAK-951 Placebo
- Keywords
- Drug Therapy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-951Drug
TAK-951 SC injection
OndansetronDrug
Ondansetron IV injection
Ondansetron PlaceboDrug
Ondansetron placebo-matching IV injection
TAK-951 PlaceboDrug
TAK-951 placebo-matching SC injection
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron 4 mg IV | Experimental | 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). Receives: Drug: Ondansetron; Drug: TAK-951 Placebo |
| TAK-951 4 mg SC | Experimental | 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). Receives: Drug: TAK-951; Drug: Ondansetron Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Complete Response in the Immediate Postoperative Period
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 the nearest single decimal.
Measured: 6 hours post-surgery (Day 1)
Secondary outcomes (15)
Percentage of Participants With Complete Response Within 24 Hours Post-Surgery
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 the nearest single decimal.
Measured: Within 24 hours post-surgery (up to Day 2)
Percentage of Participants With Emesis in the First 6 Hours Post-Surgery
Percentage of participants with emesis, defined as vomiting (the forceful discharge of even the smallest amount of stomach contents) or retching (the same muscular movements as vomiting but without expulsion of stomach contents) were reported. Percentages are rounded off to whole number at the nearest single decimal.
Measured: Within 6 hours post-surgery (Day 1)
Percentage of Participants With Emesis Within 24 Hours Post-Surgery
Percentage of participants with emesis, defined as vomiting (the forceful discharge of even the smallest amount of stomach contents) or retching (the same muscular movements as vomiting but without expulsion of stomach contents) were reported. Percentages are rounded off to whole number at the nearest single decimal.
Measured: Within 24 hours post-surgery (up to Day 2)
Percentage of Participants With Absence of Nausea in the First 6 Hours Post-Surgery
Percentage of participants without nausea, defined as urge to vomit without the presence of expulsive muscular movements were reported. Percentages are rounded off to whole number at the nearest single decimal.
Measured: Within 6 hours post-surgery (Day 1)
Percentage of Participants With Absence of Nausea in the First 24 Hours Post-Surgery
Percentage of participants without nausea, defined as urge to vomit without the presence of expulsive muscular movements were reported. CMH method was used for analysis. Percentages are rounded off to whole number at the nearest single decimal.
Measured: Within 24 hours post-surgery (up to Day 2)
Percentage of Participants Requiring Rescue Therapy for Breakthrough PONV Within 24 Hours Post-Surgery
Percentage of participants to whom rescue therapy was given as per local standard of care guidelines were reported. Percentages are rounded off to whole number at the nearest single decimal.
Measured: Within 24 hours post-surgery (up to Day 2)
Time From End of Surgery to First Emetic Event
Duration between end of wound closure to first emetic event i.e., vomiting or retching was reported. If a participant did not have an emetic event within 24 hours post-surgery, they were censored at 24 hours post-surgery. Cox proportional hazard model was used for analysis.
Measured: Within 24 hours post-surgery (up to Day 2)
Peak Nausea Verbal Rating Scale (VRS) Score
VRS was used to score postoperative nausea on 11-point numerical scale. The score ranges from 0-10, where 0 represents 'no nausea' and 10 represents 'worst nausea possible'. Higher score represents worsening of disease. Mixed-effects model for repeated measures (MMRM) was used for analysis. Least square mean (LSM) estimates extracted from MMRM are presented in the data table for each time point.
Measured: 30 minutes; 1, 2, 6, and 24 hours post-surgery (up to Day 2)
Percentage of Participants With Total Response
Percentage of participants with total response, defined as no emesis, no nausea (VRS score <1), and no need for rescue therapy were reported. VRS was used to score postoperative nausea on 11-point numerical scale, where 0 represents 'no nausea' and 10 represents 'worst nausea possible'. Percentages are rounded off to whole number at the nearest single decimal.
Measured: Within 24 hours post-surgery (up to Day 2)
TAK-951 Plasma Concentrations
Measured: 1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to Day 2)
Percentage of Participants With Any Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug. Percentages are rounded off to whole number at the nearest single decimal.
Measured: From first administration of study drug up to Day 14
Percentage of Participants With Markedly Abnormal Vital Signs
Vital signs included heart rate, respiratory rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP), body temperature and BMI. Percentage of participants with markedly abnormal vital sign values were reported. Percentages are rounded off to whole number at the nearest single decimal. Only categories with at least 1 participant with data are reported.
Measured: From first administration of study drug up to Day 14
Percentage of Participants With Clinically Significant Electrocardiogram (ECG)
Percentage of participants with clinically significant ECG interpretation were reported. Percentages are rounded off to whole number at the nearest single decimal. A combined ECG interpretation was derived using ECG heart rate, PR interval, RR interval, QRS duration, QT interval, and QT interval with Fridericia correction method (QTcF).
Measured: From first administration of study drug up to Day 14
Percentage of Participants With Markedly Abnormal Clinical Laboratory Values
Laboratory parameters included hematology and serum chemistry. Percentage of participants with markedly abnormal clinical laboratory values were reported. Percentages are rounded off to whole number at the nearest single decimal. Only categories with at least 1 participant with data are reported.
Measured: From first administration of study drug up to Day 14
Percentage of Participants With TAK-951 Antidrug Antibodies (ADA)
Percentage of participants with ADA results as: ADA negative, ADA positive were reported. Participants with ADA positive status are defined as those who had confirmed positive ADA status in baseline or at least 1 postbaseline assessments. Participants with ADA negative status are defined as those who did not have positive ADA response at baseline and in all postbaseline assessments.
Measured: Within 6 hours post-surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start20 Oct 2020
- Primary completion7 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557189
- Sponsor's protocol ID
- TAK-951-2001
- Status last verified
- Apr 2023
- First submitted
- 18 Sep 2020
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Sponsor-Open, Double-Dummy, Proof of Concept Phase 2 Study to Evaluate the Efficacy and Safety of TAK-951 Versus Ondansetron in the Prophylaxis of Postoperative Nausea and Vomiting in High-Risk Subjects
- ClinicalTrials.gov ID
- NCT04557189
- Acronym / sponsor ID
- TAK-951-2001
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The drug being tested in this study is called TAK-951. TAK-951 is being tested for prophylaxis for postoperative nausea and vomiting in high-risk participants.
The study will enroll a maximum of 160 patients, to allow a sample size of up to approximately 100 participants who have received both doses of Double-blind study drug/matching placebo. Participants will be randomly assigned in a 1:1 ratio to either Treatment Group A or Treatment Group B which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- 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.
This trial will be conducted in the United States. The overall time to participate in the study from the time of surgery to completion is approximately 14 days. Participants will make multiple visits to the clinic and will be contacted by telephone after receiving their last dose of the drug for a follow-up assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron 4 mg IV | Experimental | Drug: Ondansetron, Drug: TAK-951 PlaceboParticipants 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). |
| TAK-951 4 mg SC | Experimental | Drug: TAK-951, Drug: Ondansetron PlaceboParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants undergoing elective surgery under general anesthesia, expected to last for at least 1 hour from induction of anesthesia to wound closure.
- Participants are expected to require or have agreed to stay, at least 1 overnight in the hospital.
- Participants American Society of Anesthesiologists (ASA) physical status is ASA I-III.
- Participants with 3 or more Apfel risk factors defined as:
Key exclusion criteria (14 listed)
- Participants who are expected to remain intubated post-anesthesia.
- Participants who experience nausea or vomiting within 24 hours before surgery or are diagnosed with gastroparesis, cyclic vomiting syndrome, or other condition associated with acute or chronic nausea and vomiting.
- Participants who have received, or are expected to receive, any excluded drug preoperatively within 24 hours before induction, during surgery, or within 24 hours after surgery.
- Participants scheduled to receive neuraxial anesthesia (e.g., epidural, spinal, or caudal anesthesia), regional blocks, or total IV anesthesia, and/or planned to receive different drugs for premedication, induction, maintenance, or reversal of anesthesia than those specified in the protocol.
- Participants who have an allergy or contraindication to the recommended and available rescue therapy for the treatment of PONV.
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 |
|---|---|---|
| TAK-951TAK-951 SC injection | Drug | TAK-951 4 mg SC |
| OndansetronOndansetron IV injection | Drug | Ondansetron 4 mg IV |
| Ondansetron PlaceboOndansetron placebo-matching IV injection | Drug | TAK-951 4 mg SC |
| TAK-951 PlaceboTAK-951 placebo-matching SC injection | Drug | Ondansetron 4 mg IV |
Primary outcome
Percentage of Participants With Complete Response in the Immediate Postoperative Period
Time frame: 6 hours post-surgery (Day 1)
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 the nearest single decimal.
15 secondary outcomes
Percentage of Participants With Complete Response Within 24 Hours Post-Surgery
Time frame: Within 24 hours post-surgery (up to Day 2)
Percentage of Participants With Emesis in the First 6 Hours Post-Surgery
Time frame: Within 6 hours post-surgery (Day 1)
Percentage of Participants With Emesis Within 24 Hours Post-Surgery
Time frame: Within 24 hours post-surgery (up to Day 2)
Percentage of Participants With Absence of Nausea in the First 6 Hours Post-Surgery
Time frame: Within 6 hours post-surgery (Day 1)
Percentage of Participants With Absence of Nausea in the First 24 Hours Post-Surgery
Time frame: Within 24 hours post-surgery (up to Day 2)
Percentage of Participants Requiring Rescue Therapy for Breakthrough PONV Within 24 Hours Post-Surgery
Time frame: Within 24 hours post-surgery (up to Day 2)
Time From End of Surgery to First Emetic Event
Time frame: Within 24 hours post-surgery (up to Day 2)
Peak Nausea Verbal Rating Scale (VRS) Score
Time frame: 30 minutes; 1, 2, 6, and 24 hours post-surgery (up to Day 2)
Percentage of Participants With Total Response
Time frame: Within 24 hours post-surgery (up to Day 2)
TAK-951 Plasma Concentrations
Time frame: 1-3, 4-6, 7-9, 10-18, and 22-26 hours post-dose (up to Day 2)
Percentage of Participants With Any Treatment Emergent Adverse Event (TEAE)
Time frame: From first administration of study drug up to Day 14
Percentage of Participants With Markedly Abnormal Vital Signs
Time frame: From first administration of study drug up to Day 14
Percentage of Participants With Clinically Significant Electrocardiogram (ECG)
Time frame: From first administration of study drug up to Day 14
Percentage of Participants With Markedly Abnormal Clinical Laboratory Values
Time frame: From first administration of study drug up to Day 14
Percentage of Participants With TAK-951 Antidrug Antibodies (ADA)
Time frame: Within 6 hours post-surgery (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Medical Director study director
Takeda
7 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 TAK-951 and Ondansetron in people with Postoperative Nausea and Vomiting (PONV), run by Takeda at 7 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 8 inclusion and 14 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Complete Response in the Immediate Postoperative Period (time frame: 6 hours post-surgery (Day 1)). 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 21 Apr 2023.