Postoperative Nausea and VomitingPhase 2NCT01507194
A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)
A Phase 2 study testing Ondansetron and Vestipitant in people with Postoperative Nausea and Vomiting, run by Accenture at 7 sites in United States.
Trial summary
This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ondansetron and Vestipitant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2012to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female post-operative surgical subjects between the ages of 18-75 years.
- Female subject is of non-childbearing potential or of child-bearing potential and agrees to use specified contraception methods.
- Has 3 or more of the following independent risk factors for PONV: female gender; non-smoker; history of PONV or motion sickness; or planned post- operative opioids.
- Has received one dose of ondansetron as part of a PONV prophylaxis regimen for the surgical procedure.
- Has received general anesthesia.
- Meets ASA Physical Status Classification of 1 or 2 without an "E" modifier preoperatively on the day of surgery and has hematology and blood chemistry values within acceptable limits for surgery.
- Is capable of giving written informed consent.
- Experiences breakthrough PONV defined as: post-operative nausea of ≥ 7 on the Nausea Numeric Rating Scale; nausea resulting in a subject request for an anti-emetic; or an episode of emesis or retching.
Who cannot join
- A history of HIV.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
- An ALT or AST >2.5 x ULN at Screening.
- Pregnant or lactating females.
- The subject is scheduled to undergo a laparoscopic biopsy only.
- The subject has a history of or is scheduled to undergo cardiac/cardiothoracic surgery.
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- The subject is scheduled to receive neuraxial anesthesia(e.g., epidural, spinal, or caudal anesthesia)or total IV anesthesia.
- The subject is scheduled to receive propofol for maintenance of anesthesia (propofol as an induction agent is allowed).
- The subject is scheduled to receive an NK1 inhibitor (aprepitant/fosaprepitant) as part of a PONV prophylaxis regimen for the surgical procedure.
- The subject is scheduled to have gastric contents suctioned continuously during the surgical procedure via a nasogastric tube, or a nasogastric or oral gastric tube during the post-operative period. A single pass at the beginning or at the end of the procedure, and intraoperative gastric suctioning of air, will be permitted.
- The subject received an investigational drug within 30 days or was scheduled to receive any investigational drug in addition to vestipitant during the study period.
- The subject has persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, chemotherapy, or brain metastases.
- The subject received radiation therapy to the abdomen or the pelvis within 7 days prior to receiving study medications and/or received radiation therapy to the abdomen or the pelvis in the evaluation period.
- The subject has a history of wound dehiscence.
- The subject has a history of any other illness which might pose an unacceptable risk by administering study medication.
- The subject has any current or past medical condition (e.g., vagotomy) and/or required medication to treat a condition that could affect the evaluation of the study.
- The subject has a known contraindication or hypersensitivity to ondansetron or ondansetron injection, any scheduled anaesthetic or analgesic agents, vestipitant or any component of the vestipitant formulation including Captisol.
- The subject received medication with known or potential antiemetic activity after the induction of anaesthesia (during the intraoperative or post- operative period) other than the planned Study Treatment.
- Current or planned use of strong or moderate inhibitors of CYP3A within 7 days or inducers of CYP3A within 14 days prior to study medication administration.
- The subject is unwilling or unable to follow the procedures outlined in the protocol.
- The subject is mentally or legally incapacitated.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
CAP Anesthesia (St. Elizabeth's Medical Center)
Boston, Massachusetts, 02135
Visions Clinical Research
Boynton Beach, Florida, 33472
Precision Trials
Phoenix, Arizona, 85032
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
University of Pittsburg
Pittsburgh, Pennsylvania, 15232
Helen Keller Hospital
Sheffield, Alabama, 35660
Wake Forest University Anesthesia at Forsyth Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestipitant (GW597599), Compared With a Single 4 mg Intravenous Ondansetron Hydrochloride Dose for the Treatment of Breakthrough Post-Operative Nausea and Vomiting After Failed Prophylaxis With an Ondansetron-Containing Regimen in Patients Undergoing Non-Emergency Surgical Procedures
This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ondansetron, Vestipitant
- 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.
OndansetronDrug
Also called Zofran
Single IV dose
VestipitantDrug
Also called GW597599
Single IV dose
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron 4 mg | Active comparator | Not described Receives: Drug: Ondansetron |
| Vestipitant 6 mg | Experimental | Not described Receives: Drug: Vestipitant |
| Vestipitant 12 mg | Experimental | Not described Receives: Drug: Vestipitant |
| Vestipitant 18 mg | Experimental | Not described Receives: Drug: Vestipitant |
| Vestipitant 24 mg | Experimental | Not described Receives: Drug: Vestipitant |
| Vestipitant 36 mg | Experimental | Not described Receives: Drug: Vestipitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
No emesis and no further rescue medication
Measured: 10 min. after infusion start through 24 hrs. or discharge
Secondary outcomes (2)
Nausea Numeric Rating Scale (NNRS)
Measured: Pre-dose; 5, 10, 15 min. post-dose; q 15 min. through 2 hrs. post-dose; q 2 hrs. through 24 hrs. post-dose; and 5 days post-dose
No Emesis/Vomiting
Measured: Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accenture
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A Brigandi, MD, PhD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507194
- Sponsor's protocol ID
- VNK115640
- Status last verified
- Sep 2012
- First submitted
- 4 Jan 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
Publications
Kranke P, Thompson JP, Dalby PL, Eberhart LH, Novikova E, Johnson BM, Russ SF, Noble R, Brigandi RA. Comparison of vestipitant with ondansetron for the treatment of breakthrough postoperative nausea and vomiting after failed prophylaxis with ondansetron. Br J Anaesth. 2015 Mar;114(3):423-9. doi: 10.1093/bja/aeu376. Epub 2014 Dec 8.
PubMed 25488303
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestipitant (GW597599), Compared With a Single 4 mg Intravenous Ondansetron Hydrochloride Dose for the Treatment of Breakthrough Post-Operative Nausea and Vomiting After Failed Prophylaxis With an Ondansetron-Containing Regimen in Patients Undergoing Non-Emergency Surgical Procedures
- ClinicalTrials.gov ID
- NCT01507194
- Acronym / sponsor ID
- VNK115640
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- AccentureIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ondansetron 4 mg | Active comparator | Drug: Ondansetron |
| Vestipitant 6 mg | Experimental | Drug: Vestipitant |
| Vestipitant 12 mg | Experimental | Drug: Vestipitant |
| Vestipitant 18 mg | Experimental | Drug: Vestipitant |
| Vestipitant 24 mg | Experimental | Drug: Vestipitant |
| Vestipitant 36 mg | Experimental | Drug: Vestipitant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female post-operative surgical subjects between the ages of 18-75 years.
- Female subject is of non-childbearing potential or of child-bearing potential and agrees to use specified contraception methods.
- Has 3 or more of the following independent risk factors for PONV: female gender; non-smoker; history of PONV or motion sickness; or planned post- operative opioids.
- Has received one dose of ondansetron as part of a PONV prophylaxis regimen for the surgical procedure.
- Has received general anesthesia.
Key exclusion criteria (21 listed)
- A history of HIV.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
- An ALT or AST >2.5 x ULN at Screening.
- Pregnant or lactating females.
- The subject is scheduled to undergo a laparoscopic biopsy only.
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 |
|---|---|---|
| OndansetronAlso: ZofranSingle IV dose | Drug | Ondansetron 4 mg |
| VestipitantAlso: GW597599Single IV dose | Drug | Vestipitant 12 mg, Vestipitant 18 mg, Vestipitant 24 mg, Vestipitant 36 mg, Vestipitant 6 mg |
Primary outcome
Complete Response
Time frame: 10 min. after infusion start through 24 hrs. or discharge
No emesis and no further rescue medication
2 secondary outcomes
Nausea Numeric Rating Scale (NNRS)
Time frame: Pre-dose; 5, 10, 15 min. post-dose; q 15 min. through 2 hrs. post-dose; q 2 hrs. through 24 hrs. post-dose; and 5 days post-dose
No Emesis/Vomiting
Time frame: Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Derived from this study: PubMed 25488303Kranke P, Thompson JP, Dalby PL, Eberhart LH, Novikova E, Johnson BM, Russ SF, Noble R, Brigandi RA. Comparison of vestipitant with ondansetron for the treatment of breakthrough postoperative nausea and vomiting after failed prophylaxis with ondansetron. Br J Anaesth. 2015 Mar;114(3):423-9. doi: 10.1093/bja/aeu376. Epub 2014 Dec 8.
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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.
Richard A Brigandi, MD, PhD study director
GlaxoSmithKline
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 Ondansetron and Vestipitant in people with Postoperative Nausea and Vomiting, run by Accenture 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 21 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 2 Oct 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete Response (time frame: 10 min. after infusion start through 24 hrs. or discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507194, which also lists 1 linked publication.
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 2 Oct 2012.