Last updated: 11/07/2018 09:41:32
VNK115640: 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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: VNK115640: 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
Trial description: VNK115640: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Kranke P, Thompson J, Novikova E, Dalby P, Eberhart L, Johnson B, Russ S, Noble R, Brigandi R.Comparison of Vestipitant with Ondansetron for the Treatment of Breakthrough Postoperative Nausea and Vomiting after Failed Prophylaxis with Ondansetron.Br J Anaesth.2014
Kranke P, Thompson J, Novikova E, Dalby P, Eberhart L, Johnson B, Russ S, Noble R, Brigandi R.Comparison of Vestipitant with Ondansetron for the Treatment of Breakthrough Postoperative Nausea and Vomiting after Failed Prophylaxis with Ondansetron.Br J Anaesth.2015;114(3):423-429
Medical condition
Nausea and Vomiting, Postoperative
Product
ondansetron, vestipitant
Collaborators
Not applicable
Study date(s)
March 2012 to August 2012
Type
Not applicable
Phase
1/2
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-28-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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