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

NCT01507194 | Completed Phase 2

• 1 other identifier: VNK115640
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Complete Response

  No emesis and no further rescue medication

  10 min. after infusion start through 24 hrs. or discharge

Secondary Outcomes (2)

• Nausea Numeric Rating Scale (NNRS)

  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

  Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose

Study Arms (6)

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

Interventions

Ondansetron DRUG

Single IV dose

Also known as: Zofran

Ondansetron 4 mg

Vestipitant DRUG

Single IV dose

Also known as: GW597599

Vestipitant 12 mg; Vestipitant 18 mg; Vestipitant 24 mg; Vestipitant 36 mg; Vestipitant 6 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Accenture: lead

Study Sites (7)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

CAP Anesthesia (St. Elizabeth's Medical Center)

Boston, Massachusetts, 02135, United States

Location

Wake Forest University Anesthesia at Forsyth Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburg

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• 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.

  PMID: 25488303 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; vestipitant

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Richard A Brigandi, MD, PhD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 10, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

US (7)