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ondansetron

Phase 2

Postoperative Nausea and Vomiting | Small molecule | Other |GSK plc|Last Updated: Nov 13, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment701

FDA Designations

No designations recorded

Clinical trial landscape

ondansetron · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00108095A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And VomitingPostoperative Nausea and Vomiting
COMPLETED701 Analytics
PHASE2COMPLETED
A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
Postoperative Nausea and Vomiting
NCT00108095701
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Study Endpoints

Primary Endpoints

Number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following emergence from anesthesia
Change in QTcF after a single dose of Ondansetron given IV over 15 minutes.
Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject's participation in the study, from screening through follow-up will be an average of 11 weeks.

Two doses of ondansetron willl be used, 8mg and 32mg. The change in QTcF will be time-matched, baseline adjusted and compared to placebo.

Secondary Endpoints

Number of subjects who achieve a complete response during each subsequent 24 hour evaluation period (up to 120 hours)following the emergence from anesthesia
The extent of nausea experienced by subjects.
characterize relationship between changes in ddQTc and plasma concentrations of ondansetron
Single dosing day at each of the 4 treatment periods with a 7-day washout between each period. The total duration of each subject's participation in the study, from screening through follow-up will be an average of 11 weeks.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ondansetron, 8 mg IV over 15 minutesACTIVE_COMPARATORthe lower ondansetron IV dose will be used in one of the four treatment periods
ondansetron, 32 mg IV over 15 minutesACTIVE_COMPARATORthe higher ondansetron IV dose will be used in one of the four treatment periods
placebo for ondansetron, IV over 15 minutesPLACEBO_COMPARATORplacebo for ondansetron IV dose will be used in one of the four treatment periods
moxifloxacin, 400mg tablet (oral)ACTIVE_COMPARATORmoxifloxacin is known to produce mild QT prolongation and will be used in one of the four treatment periods

Interventions

NameTypeDescription
intravenous ondansetronDRUG -
ondansetronDRUGFDA approved drug used to treat nausea and vomiting
moxifloxacinDRUGFDA approved antibiotic commonly used as a positive control in thorough QT studies
salineOTHERUSP saline IV solution used as placebo for ondansetron IV.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexFEMALE
Healthy VolunteersNo
Study Sites58

Inclusion criteria: * Females age 18-55 * Laparoscopic/laparotomic gynecological procedure of laparoscopic gallbladder removal Exclusion criteria: * Pregnant or breastfeeding * Post-menopausal * Not undergoing general anesthesia

Countries:United StatesBelgiumCanadaGermanyHungarySpain
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Frequently asked questions about ondansetron

What is ondansetron used for?

Ondansetron is used for postoperative nausea and vomiting, nausea and vomiting, and chemotherapy-induced nausea and vomiting. It is a small molecule being developed by GSK plc for these indications.

What does ondansetron target?

Ondansetron targets the 5-HT3 receptor, a serotonin receptor involved in triggering nausea and vomiting. By blocking this receptor, it helps prevent and treat nausea and vomiting associated with surgery and chemotherapy.

Who makes ondansetron?

Ondansetron is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the drug for various nausea and vomiting indications.

What phase is ondansetron in?

Ondansetron is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy.

What clinical trials is ondansetron in?

Ondansetron has been studied in clinical trials including NCT00108095, a Phase 2 study in postoperative nausea and vomiting, and NCT01449188, a Phase 1 study on cardiac conduction in healthy subjects. Both trials have been completed.

Is ondansetron the same as Zofran?

Ondansetron is the generic name for the drug also known as Zofran. It is used to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. GSK plc is the developer of this medication.