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GW406381

Phase 3

Arthritis, Rheumatoid | Small molecule | Immunology |GSK plc|Last Updated: Sep 11, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment2,208

FDA Designations

No designations recorded

Clinical trial landscape

GW406381 · 5 trials · 8 indications

Phase 3 3Phase 1 2
NCT00113308COX-2 Inhibitor Study In Patients With Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED2,208 Analytics
NCT00120900Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The KneeOsteoarthritis, Knee
COMPLETED1,340 Analytics
NCT00114049Dental Pain (Following Third Molar Tooth Extraction) StudyDental Pain
COMPLETED300 Analytics
PHASE3COMPLETED
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
Arthritis, Rheumatoid
NCT001133082,208
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PHASE3COMPLETED
Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee
Osteoarthritis, Knee
NCT001209001,340
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PHASE3COMPLETED
Dental Pain (Following Third Molar Tooth Extraction) Study
Dental Pain
NCT00114049300
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Study Endpoints

Primary Endpoints

Percentage of American College of Rheumatology (ACR)20 Responders at Week 12
Week 12
Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
Difference between treatments over time based on pain intensity and pain relief scores.
GW406381 pharmacokinetic parameters AUC and Cmax
throughout the study
To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury

Secondary Endpoints

Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)
Baseline and Week 12
Change from baseline to each scheduled visit in swollen joint count (66 joint panel)
Baseline and Week 12
Change from baseline to each scheduled visit in patient's pain assessment (VAS)
Baseline and Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving GW406381EXPERIMENTALSubjects will receive single oral dose of 20 milligram (mg) of GW406381.

Interventions

NameTypeDescription
GW406381DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites341

Inclusion criteria: * Rheumatoid arthritis (RA) for at least 12 months. * Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening. Exclusion criteria: * Any history of cardiovascular disease (e....

Countries:United StatesArgentinaAustriaBelgiumBulgariaCanadaChileCosta RicaDenmarkFinlandFranceGermanyGreeceHungaryIndiaIrelandItalyLatviaMexicoNetherlandsNew ZealandNorwayPeruPhilippinesPolandPuerto RicoRomaniaRussiaSouth AfricaSouth KoreaSpainUkraineUnited KingdomSweden
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Frequently asked questions about GW406381

What is GW406381 used for?

GW406381 is an investigational small molecule being studied for pain-related conditions, including osteoarthritis of the knee, rheumatoid arthritis, dental pain, and hyperalgesia. It has been evaluated in clinical trials for these indications, though it remains in clinical development and is not approved.

What does GW406381 target?

GW406381 is a COX-2 inhibitor, as indicated by the title of its Phase 3 trial in rheumatoid arthritis. It is designed to inhibit the COX-2 enzyme, which plays a role in inflammation and pain. This mechanism is being investigated for treating conditions like osteoarthritis and rheumatoid arthritis.

Who makes GW406381?

GW406381 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. GSK has sponsored clinical trials of GW406381 across multiple countries to evaluate its safety and efficacy in pain-related conditions.

What phase is GW406381 in?

GW406381 has completed Phase 3 clinical trials for rheumatoid arthritis and osteoarthritis of the knee, as well as Phase 1 trials for other pain conditions. However, it is not approved and remains an investigational drug, with no active trials currently listed.

What clinical trials is GW406381 in?

GW406381 has been studied in several completed trials, including NCT00113308 for rheumatoid arthritis, NCT00120900 for osteoarthritis of the knee, NCT00279032 for peripheral nerve injury, and NCT00373243 for pain in hepatic impairment. All trials are completed, with no active studies ongoing.

Is GW406381 the same as a COX-2 inhibitor?

Yes, GW406381 is a COX-2 inhibitor, as indicated by the title of its Phase 3 trial in rheumatoid arthritis. This class of drugs targets the COX-2 enzyme to reduce inflammation and pain, and GW406381 is being investigated for conditions like osteoarthritis and rheumatoid arthritis.