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GR68755

Phase 2

Irritable Colon | Small molecule | Gastrointestinal |GSK plc|Last Updated: May 1, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

GR68755 · 1 trial · 1 indication

Phase 2 1
NCT01855711Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)Irritable Colon
COMPLETED32 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)
Irritable Colon
NCT0185571132
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Study Endpoints

Primary Endpoints

Global Improvement Scale(GIS)
four weeks
Satisfactory control of IBS related bowel urgency
four weeks

Secondary Endpoints

Adequate relief of IBS pain and discomfort
four weeks
Days without abdominal pain and discomfort
four weeks
Severity score of abdominal pain and/or discomfort
four weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GR68755 (Alosetron hydrochrolide) groupEXPERIMENTALGR68755 1 mg tablets QD in the morning every day for 28 days

Interventions

NameTypeDescription
GR68755 (Alosetron hydrochloride) 1 mg tabletDRUG1 tablet (1 mg) once a day
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Eligibility Criteria

Age Range20 Years to 64 Years
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Disease to be treated: Has been diagnosed with severe d-IBS (at least 6 months of d-IBS symptoms as defined by the Rome II Criteria), and failed conventional IBS therapy. ...

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Frequently asked questions about GR68755

What is GR68755 used for?

GR68755 is a small molecule being studied for the treatment of irritable colon, specifically severe diarrhea-predominant irritable bowel syndrome (IBS). It is currently in Phase 2 clinical development and is intended for use in female patients aged 20 years and older.

Who makes GR68755?

GR68755 is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this investigational small molecule for gastrointestinal conditions, particularly severe diarrhea-predominant irritable bowel syndrome.

What phase is GR68755 in?

GR68755 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is GR68755 in?

GR68755 has one completed clinical trial, identified as NCT01855711. This Phase 2 study evaluated the safety and efficacy of GR68755 (alosetron hydrochloride) in treating severe diarrhea-predominant irritable bowel syndrome. The trial enrolled 32 female participants and was not randomized, double-blind, or controlled.

Is GR68755 the same as alosetron hydrochloride?

Yes, GR68755 is also known as alosetron hydrochloride. The clinical trial NCT01855711 refers to GR68755 as alosetron hydrochloride, indicating that these names refer to the same investigational drug being studied for severe diarrhea-predominant irritable bowel syndrome.