Clinical trial NCT00447486: A Study of GW842166 in Adults With Osteoarthritis Pain
Official title: A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis,
knee,
GW842166,
pain,
efficacy,
safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 308
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether GW842166 is effective in the treatment of osteoarthritis pain of the knee.


Eligibility criteria: Inclusion Criteria:

* male or female outpatient, \>= 40 years of age
* meets ACR clinical and radiographic criteria for classification of idiopathic (primary) osteoarthritis of the knee with symptom duration for at least 3 months
* meets ARA functional status requirements
* meets WOMAC pain subscale score requirements
* has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days in each of the 4 weeks preceding screen

Exclusion Criteria:

* any pre-specified clinical/biological/ECG abnormality
* any pre-specified drug sensitivity
* history of peptic ulceration or GI bleeding
* use of protocol-specified medications
* secondary cause of knee OA
* lower extremity surgery within 6 months of screening
* use of analgesics other than allowed per protocol
* use of corticosteroids or hyaluronan outside of allowed window prior to screening

Primary outcomes:
measure: The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
timeFrame: 4 Weeks
Secondary outcomes:
measure: WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Odense C
country: Denmark
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Centelles
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Petrer/Alicante
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
city: Höllviken
country: Sweden
facility: GSK Investigational Site
city: Stocholm
country: Sweden
facility: GSK Investigational Site
city: Upplands Väsby
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, BSc MB PhD
role: STUDY_DIRECTOR
References: