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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 m

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Trial Conditions
  • Postoperative Nausea and Vomiting
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18  - 75 

Gender:
Both

Eligibility

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.

Gender: Both
Steward Physician(s)
  • Richard A Brigandi, MD, PhD
Trial Interventions
Drug
  • Ondansetron
  • Vestipitant
Physician Researcher

Investigator Name:

  • Richard A Brigandi, MD, PhD

Other Information

Sponsor: Octagon Research Solutions, Inc.
Phase: Phase 2
Trial ID: NCT01507194
Volunteers:  Not Accepting Healthy Volunteers

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