Clinical trial NCT00120900: Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee
Official title: A Phase III, 12-week, Multicentre, Double-Blind, Double-Dummy, Randomised, Placebo - and Active Comparator - Contolled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381 XXmg and YYmg Administered Orally Once Daily, in Adults With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: COX-2 inhibitor
Knee osteoarthritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-19
Enrollment: 1340
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.

Detailed description: A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee (CXA30007).

Eligibility criteria: Inclusion criteria:

* Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
* Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.

Exclusion criteria:

* History of hypersensitivity or intolerance to pain medications.
* History of gastroduodenal perforations and/or obstructions.
* History of upper GI (gastrointestinal) ulceration within the previous 6 months.
* History of upper or lower GI bleeding within the previous year.
* History of inflammatory bowel disease.
* Currently take sucralfate or misoprostol.
* Currently taking aspirin daily for the heart.
* Other restrictions around the use medications apply and would need to be discussed.
* History of coronary artery disease, (angina, MI) or surgery.
* History of congestive heart failure or renal artery stenosis.
* History of stroke or transient ischemic attack.
* History of uncontrolled hypertension.

Primary outcomes:
measure: Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
Secondary outcomes:
measure: Change in OA symptoms as measured by subject and physician-completed questionnaires at each scheduled visit. Percentage of responders, subjects discontinuing due to lack of efficacy, use of rescue medication and health-related quality of life.
Other outcomes:
Locations:
city: Ishoj
country: Denmark
facility: GSK Investigational Site
city: Anyang-Si
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: De Bilt
country: Netherlands
facility: GSK Investigational Site
city: Ewijk
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Hamar
country: Norway
facility: GSK Investigational Site
city: Hønefoss
country: Norway
facility: GSK Investigational Site
city: Lier
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: San Juan
country: Spain
facility: GSK Investigational Site
city: Helsingborg
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: