search
Back to results

Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GW406381
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring COX-2 inhibitor, Knee osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2005
Last Updated
January 18, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00120900
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
COX-2 inhibitor, Knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1340 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW406381
Primary Outcome Measure Information:
Title
Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ishoj
ZIP/Postal Code
2635
Country
Denmark
Facility Name
GSK Investigational Site
City
Anyang-Si
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
De Bilt
ZIP/Postal Code
3731 DN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Ewijk
ZIP/Postal Code
6644 CL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Heerlen
ZIP/Postal Code
6416 EG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Bergen
ZIP/Postal Code
N-5068
Country
Norway
Facility Name
GSK Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
GSK Investigational Site
City
Hønefoss
ZIP/Postal Code
N-3515
Country
Norway
Facility Name
GSK Investigational Site
City
Lier
ZIP/Postal Code
3400
Country
Norway
Facility Name
GSK Investigational Site
City
Oslo
ZIP/Postal Code
N-0370
Country
Norway
Facility Name
GSK Investigational Site
City
San Juan
Country
Spain
Facility Name
GSK Investigational Site
City
Helsingborg
ZIP/Postal Code
SE-252 78
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

We'll reach out to this number within 24 hrs