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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Accenture
ClinicalTrials.gov Identifier:
NCT01507194
First received: January 4, 2012
Last updated: September 30, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Ondansetron
Drug: Vestipitant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Accenture:

Primary Outcome Measures:
  • Complete Response [ Time Frame: 10 min. after infusion start through 24 hrs. or discharge ] [ Designated as safety issue: No ]
    No emesis and no further rescue medication


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • No Emesis/Vomiting [ Time Frame: Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ondansetron 4 mg Drug: Ondansetron
Single IV dose
Other Name: Zofran
Experimental: Vestipitant 6 mg Drug: Vestipitant
Single IV dose
Other Name: GW597599
Experimental: Vestipitant 12 mg Drug: Vestipitant
Single IV dose
Other Name: GW597599
Experimental: Vestipitant 18 mg Drug: Vestipitant
Single IV dose
Other Name: GW597599
Experimental: Vestipitant 24 mg Drug: Vestipitant
Single IV dose
Other Name: GW597599
Experimental: Vestipitant 36 mg Drug: Vestipitant
Single IV dose
Other Name: GW597599

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507194

Locations
United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
Precision Trials
Phoenix, Arizona, United States, 85032
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
United States, Massachusetts
CAP Anesthesia (St. Elizabeth's Medical Center)
Boston, Massachusetts, United States, 02135
United States, North Carolina
Wake Forest University Anesthesia at Forsyth Medical Center
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
University of Pittsburg
Pittsburgh, Pennsylvania, United States, 15232
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Accenture
Investigators
Study Director: Richard A Brigandi, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Accenture
ClinicalTrials.gov Identifier: NCT01507194     History of Changes
Other Study ID Numbers: VNK115640
Study First Received: January 4, 2012
Last Updated: September 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Vestipitant
Neurokinin-1 Receptor Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on August 21, 2014