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GW427353

Phase 2

Irritable Bowel Syndrome (IBS) | Small molecule | Gastrointestinal |GSK plc|Last Updated: May 18, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

GW427353 · 1 trial · 1 indication

Phase 2 1
NCT00394186A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)Irritable Bowel Syndrome (IBS)
COMPLETED100 Analytics
PHASE2COMPLETED
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
Irritable Bowel Syndrome (IBS)Unlock trial analytics

Study Endpoints

Primary Endpoints

completion of questionnaires by the subject, determining the average adequate relief rate
during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)

Secondary Endpoints

Blood levels of GW427353
Week 1, 13
Questionnaire
Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
each visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Interventions

NameTypeDescription
GW427353DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: \- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be \> 1.5 (0= no pain, 4 = very severe pain) Exclusion Criteria: * Subjects not meeting the Rome II criteria for the diagnosis of IBS * Subjects with no stool for 7 days during the screen

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

Frequently asked questions about GW427353

What is GW427353 used for?

GW427353 is an investigational small molecule being studied for the treatment of Irritable Bowel Syndrome (IBS). It is in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in patients with IBS to assess its safety and efficacy.

Who makes GW427353?

GW427353 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's potential in treating Irritable Bowel Syndrome (IBS).

What phase is GW427353 in?

GW427353 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for commercial use. The Phase 2 trial for GW427353 in Irritable Bowel Syndrome (IBS) has been completed.

What clinical trials is GW427353 in?

GW427353 has one completed Phase 2 clinical trial registered under NCT00394186, titled "A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)." The trial enrolled 100 participants with IBS across Australia, France, and Germany. It was a randomized, double-blind study.

How does GW427353 work?

The molecular target and mechanism of action for GW427353 have not been disclosed in available information. The drug is being studied for its potential effects in treating Irritable Bowel Syndrome (IBS), but its specific biological pathway remains undisclosed.