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Ondansetron

Phase 3

IBS - Irritable Bowel Syndrome | Small molecule | Gastrointestinal |National Healthcare Corp.|Last Updated: Aug 7, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Ondansetron · 1 trial · 1 indication

Phase 3 1
NCT03555188TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron TrialIBS - Irritable Bowel Syndrome
COMPLETED80 Analytics
PHASE3COMPLETED
TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial
IBS - Irritable Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Weekly responder for abdominal pain and stool consistency
12 weeks

Measured at 12 weeks post randomisation and defined, as recommended by the FDA, as patient being a weekly responder for BOTH pain intensity AND stool consistency for at least 6 weeks in the 12 week treatment period.

Secondary Endpoints

Stool Frequency
12 weeks
Stool Consistency
12 weeks
Urgency of defecation
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OndansetronEXPERIMENTALTaken orally 4mg-24mg daily for 12 weeks. Dose to be amended throughout according to symptoms.
PlaceboPLACEBO_COMPARATORTaken orally 4mg-24mg daily for 12 weeks. Dose to be amended throughout according to symptoms.

Interventions

NameTypeDescription
OndansetronDRUGOndansetron is a highly selective receptor antagonist (5-HT3RA)
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Written (signed and dated) informed consent. 2. Considered fit for study participation. 3. Meeting Rome IV criteria for IBS-D 4. Aged ≥ 18 years 5. Undergone standardised workup to exclude the following alternative diagnoses: 1. Microscopic colitis (colonoscopy or flexibl...

Countries:United Kingdom
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Competitive Landscape -Irritable Bowel Syndrome 12 trials (matched to "IBS - Irritable Bowel Syndrome")

Frequently asked questions about Ondansetron

What is Ondansetron used for in IBS?

Ondansetron is being studied for the treatment of Irritable Bowel Syndrome (IBS), specifically in a Phase 3 clinical trial. It is a small molecule being developed by National Healthcare Corp. for this gastrointestinal condition.

What does Ondansetron target?

Ondansetron targets the serotonin 5-HT3 receptor. By blocking this receptor, it may help manage symptoms of Irritable Bowel Syndrome (IBS). The drug is currently in Phase 3 clinical development for this indication.

Who makes Ondansetron?

Ondansetron is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting a Phase 3 clinical trial for the drug in Irritable Bowel Syndrome (IBS).

What phase is Ondansetron in for IBS?

Ondansetron is in Phase 3 clinical development for Irritable Bowel Syndrome (IBS). It is an investigational drug, and the Phase 3 trial has been completed. The drug is not yet approved for this indication.

What clinical trials is Ondansetron in?

Ondansetron has one completed Phase 3 trial, NCT03555188, titled 'TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial'. This randomized, double-blind, placebo-controlled study enrolled 80 participants in the United Kingdom.

Is Ondansetron the same as Zofran?

Ondansetron is the generic name for the drug also known as Zofran. In the context of Irritable Bowel Syndrome (IBS), it is being studied under the name Ondansetron in a Phase 3 clinical trial by National Healthcare Corp.