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GS856553

Phase 2

Pain, Neuropathic | Small molecule | Pain |GSK plc|Last Updated: Jun 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

GS856553 · 1 trial · 1 indication

Phase 2 1
NCT01110057Efficacy Study in Lumbosacral RadiculopathyPain, Neuropathic
COMPLETED142 Analytics
PHASE2COMPLETED
Efficacy Study in Lumbosacral Radiculopathy
Pain, Neuropathic
NCT01110057142
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Study Endpoints

Primary Endpoints

Change in average daily neuropathic pain score from Baseline up to Week 5 (Week 4 of double blind treatment) of treatment
Baseline (Day -7 to Day -1) and up to 5 weeks

The scores were analyzed based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) with 0 score indicating no pain and score of 10 indicating maximum pain. The adjusted mean values are represented as least square mean (LS mean) values.

Secondary Endpoints

Change in average daily pain intensity rating score (PI-NRS) from Baseline (Day -7 to Day -1) to 5 Weeks
Baseline (Day -7 to Day -1) and up to 5 weeks
Change in pain quality on the Short-Form McGill Pain Questionnaire (SF-MPQ) from Baseline up to 5 weeks.
Baseline (Day -7 to Day -1) and up to 5 weeks
Number of participants with intensities of pain by SF-MPQ method over 5 weeks
From Baseline (Day -7 to Day -1) up to 5 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALGW856553
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
PlaceboDRUGPlacebo to match GW856553
GS856553DRUGGW586553 7.5mg bid
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites17

Key Inclusion Criteria: * Male or female subjects aged 18 - 80 years inclusive, at the time of signing the informed consent. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or...

Countries:DenmarkFranceGermanyNorwaySweden
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Competitive Landscape -Neuropathic Pain 9 trials (matched to "Pain, Neuropathic")

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE2LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA
Dogwood Therapeutics IncDWTX1PHASE2Halneuron
Sangamo Therapeutics, Inc.SGMO1PHASE1ST-503
Boston Scientific CorporationBSX1N/AUndisclosed
Collegium Pharmaceutical, Inc.COLL1N/AUndisclosed
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Frequently asked questions about GS856553

What is GS856553 used for?

GS856553 is an investigational small molecule being developed for the treatment of neuropathic pain. It was studied in a Phase 2 clinical trial for lumbosacral radiculopathy, a condition involving nerve root compression that causes radiating pain. The drug is not approved and remains in clinical development.

Who makes GS856553?

GS856553 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is responsible for the drug's research and clinical development program.

What phase is GS856553 in?

GS856553 is in Phase 2 clinical development. A Phase 2 efficacy study in lumbosacral radiculopathy has been completed. The drug is investigational and has not received regulatory approval for any indication.

What clinical trials is GS856553 in?

GS856553 has one completed Phase 2 clinical trial registered as NCT01110057, titled "Efficacy Study in Lumbosacral Radiculopathy." The trial enrolled 142 participants with neuropathic pain and was conducted in Denmark, France, Germany, Norway, and Sweden.

How does GS856553 work?

GS856553 is a small molecule, but its specific molecular target has not been disclosed. As a result, the exact mechanism of action for its potential effect on neuropathic pain is not publicly available.

Is GS856553 FDA approved?

GS856553 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for neuropathic pain associated with lumbosacral radiculopathy. The drug remains in clinical development and has not been authorized for marketing.