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

NCT ID: NCT01507194

Last Updated: 2012-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ondansetron 4 mg

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

Single IV dose

Vestipitant 6 mg

Group Type: EXPERIMENTAL

Vestipitant

Intervention Type: DRUG

Single IV dose

Vestipitant 12 mg

Group Type: EXPERIMENTAL

Vestipitant

Intervention Type: DRUG

Single IV dose

Vestipitant 18 mg

Group Type: EXPERIMENTAL

Vestipitant

Intervention Type: DRUG

Single IV dose

Vestipitant 24 mg

Group Type: EXPERIMENTAL

Vestipitant

Intervention Type: DRUG

Single IV dose

Vestipitant 36 mg

Group Type: EXPERIMENTAL

Vestipitant

Intervention Type: DRUG

Single IV dose

Interventions

Ondansetron

Single IV dose

Intervention Type: DRUG

Vestipitant

Single IV dose

Intervention Type: DRUG

Other Intervention Names

Zofran; GW597599

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accenture

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A Brigandi, MD, PhD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Helen Keller Hospital

Sheffield, Alabama, United States

Precision Trials

Phoenix, Arizona, United States

Visions Clinical Research

Boynton Beach, Florida, United States

CAP Anesthesia (St. Elizabeth's Medical Center)

Boston, Massachusetts, United States

Wake Forest University Anesthesia at Forsyth Medical Center

Winston-Salem, North Carolina, United States

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

University of Pittsburg

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25488303 (View on PubMed)

Other Identifiers

VNK115640

Identifier Type: -

Identifier Source: org_study_id