A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)

September 30, 2012 updated by: Accenture

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Helen Keller Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • CAP Anesthesia (St. Elizabeth's Medical Center)
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest University Anesthesia at Forsyth Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ondansetron 4 mg
Drug: Ondansetron
Single IV dose
Other Names:
  • Zofran
EXPERIMENTAL: Vestipitant 6 mg
Drug: Vestipitant
Single IV dose
Other Names:
  • GW597599
EXPERIMENTAL: Vestipitant 12 mg
Drug: Vestipitant
Single IV dose
Other Names:
  • GW597599
EXPERIMENTAL: Vestipitant 18 mg
Drug: Vestipitant
Single IV dose
Other Names:
  • GW597599
EXPERIMENTAL: Vestipitant 24 mg
Drug: Vestipitant
Single IV dose
Other Names:
  • GW597599
EXPERIMENTAL: Vestipitant 36 mg
Drug: Vestipitant
Single IV dose
Other Names:
  • GW597599

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response
Time Frame: 10 min. after infusion start through 24 hrs. or discharge
No emesis and no further rescue medication
10 min. after infusion start through 24 hrs. or discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accenture

Investigators

  • Study Director: Richard A Brigandi, MD, PhD, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (ESTIMATE)

January 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2012

Last Update Submitted That Met QC Criteria

September 30, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNK115640

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Nausea and Vomiting

Clinical Trials on Ondansetron

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe