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

January 4, 2012
September 30, 2012
February 2012
August 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01507194 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Postoperative Nausea and Vomiting
  • Drug: Ondansetron
    Single IV dose
    Other Name: Zofran
  • Drug: Vestipitant
    Single IV dose
    Other Name: GW597599
  • Active Comparator: Ondansetron 4 mg
    Intervention: Drug: Ondansetron
  • Experimental: Vestipitant 6 mg
    Intervention: Drug: Vestipitant
  • Experimental: Vestipitant 12 mg
    Intervention: Drug: Vestipitant
  • Experimental: Vestipitant 18 mg
    Intervention: Drug: Vestipitant
  • Experimental: Vestipitant 24 mg
    Intervention: Drug: Vestipitant
  • Experimental: Vestipitant 36 mg
    Intervention: Drug: Vestipitant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01507194
VNK115640
Not Provided
Accenture
Accenture
Not Provided
Study Director: Richard A Brigandi, MD, PhD GlaxoSmithKline
Accenture
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP