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GW406381

Phase 3

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

GW406381 development status

Highest phase Phase 3
Registered trials 5 across 1 sponsor since Jun 2005

GW406381 target and mechanism

Molecular targetPTGS2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment3,912

FDA Designations

No designations recorded

GW406381 clinical trials

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, RheumatoidUnlock trial analytics
PHASE3COMPLETED
Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee
Osteoarthritis, KneeUnlock trial analytics
PHASE3COMPLETED
Dental Pain (Following Third Molar Tooth Extraction) Study
Dental PainUnlock trial analytics

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?

GW406381 is an investigational small molecule drug developed by GSK plc for pain and inflammatory conditions. It has been studied in arthritis, rheumatoid arthritis, osteoarthritis of the knee, dental pain, and hyperalgesia. It reached Phase 3 clinical development but is not described as approved.

What is GW406381 used for?

GW406381 has been studied for pain and inflammatory conditions including osteoarthritis of the knee, rheumatoid arthritis, dental pain following third molar tooth extraction, and hyperalgesia associated with peripheral nerve injury. These studies were conducted in adults, and the drug remains investigational.

What does GW406381 target?

GW406381 targets PTGS2, also known as cyclooxygenase-2 or COX-2. It acts as an inhibitor of this enzyme. PTGS2 inhibition is the mechanism behind its investigation for pain and inflammatory conditions such as osteoarthritis and dental pain.

Who makes GW406381?

GW406381 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials evaluating the drug in osteoarthritis of the knee, dental pain, peripheral nerve injury, and hepatic impairment.

What phase is GW406381 in?

GW406381 reached Phase 3 clinical development. A Phase 3 trial evaluated it in adults with osteoarthritis of the knee, and another Phase 3 trial studied it in dental pain following third molar tooth extraction. It is an investigational drug and is not described as approved.

What clinical trials is GW406381 in?

GW406381 has been studied in completed trials including NCT00120900 in osteoarthritis of the knee, NCT00114049 in dental pain after third molar extraction, NCT00279032 in patients with peripheral nerve injury, and NCT00373243 in volunteers with moderate hepatic impairment. All four trials are listed as completed.