Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120900
• Other study ID #: CXA30007
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: January 18, 2017
• Start date: May 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1340
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• GW406381

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Ishoj
Korea, Republic of	GSK Investigational Site	Anyang-Si
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Netherlands	GSK Investigational Site	De Bilt
Netherlands	GSK Investigational Site	Ewijk
Netherlands	GSK Investigational Site	Heerlen
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Hamar
Norway	GSK Investigational Site	Hønefoss
Norway	GSK Investigational Site	Lier
Norway	GSK Investigational Site	Oslo
Spain	GSK Investigational Site	San Juan
Sweden	GSK Investigational Site	Helsingborg

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Korea, Republic of,  Netherlands,  Norway,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
Secondary	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.