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alosetron

Phase 3

Irritable Colon | Small molecule | Gastrointestinal |GSK plc|Last Updated: Apr 16, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment1,402

FDA Designations

No designations recorded

Clinical trial landscape

alosetron · 2 trials · 2 indications

Phase 3 2
NCT00067457Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional TherapyIrritable Colon
COMPLETED700 Analytics
NCT00067561Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional TherapyIrritable Colon
COMPLETED702 Analytics
PHASE3COMPLETED
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Irritable ColonUnlock trial analytics
PHASE3COMPLETED
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Irritable ColonUnlock trial analytics

Study Endpoints

Primary Endpoints

Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.
12 Weeks

Secondary Endpoints

Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.
12 Weeks
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
alosetronDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites191

Inclusion Criteria: * Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS). * Failed conventional therapy. * Willing to make daily calls on a touch-tone telephone. Exclusion criteria: * History of or current chronic or severe constipation. * Bloody diarrhea, abdominal pain wi...

Countries:United StatesAustralia
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Frequently asked questions about alosetron

What is alosetron used for?

Alosetron is an investigational small molecule being developed for irritable colon, specifically for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have failed conventional therapy. It is in Phase 3 clinical development and has not been approved by the FDA.

Who makes alosetron?

Alosetron is being developed by GSK plc, which trades under the ticker GSK. The company is conducting Phase 3 clinical trials for the drug in the gastrointestinal therapeutic area.

What phase is alosetron in?

Alosetron is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials have been completed, both in women with severe diarrhea-predominant irritable bowel syndrome.

What clinical trials is alosetron in?

Alosetron has two completed Phase 3 trials: NCT00067457 and NCT00067561. Both enrolled women with severe diarrhea-predominant irritable bowel syndrome who had failed conventional therapy, with a combined enrollment of 1,402 participants across the United States and Australia.

How does alosetron work?

Alosetron is a small molecule drug. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not described here.