NCT00120900

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,340

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2005

Geographic Reach
6 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

June 30, 2005

Last Update Submit

January 18, 2017

Conditions

Osteoarthritis, Knee

Keywords

COX-2 inhibitorKnee osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

GW406381DRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

GSK Investigational Site

Ishøj, 2635, Denmark

Location

GSK Investigational Site

De Bilt, 3731 DN, Netherlands

Location

GSK Investigational Site

Ewijk, 6644 CL, Netherlands

Location

GSK Investigational Site

Heerlen, 6416 EG, Netherlands

Location

GSK Investigational Site

Bergen, N-5068, Norway

Location

GSK Investigational Site

Hamar, 2317, Norway

Location

GSK Investigational Site

Hønefoss, N-3515, Norway

Location

GSK Investigational Site

Lier, 3400, Norway

Location

GSK Investigational Site

Oslo, N-0370, Norway

Location

GSK Investigational Site

Anyang-si, 431-070, South Korea

Location

GSK Investigational Site

Daegu, 705-718, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 133-792, South Korea

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Seoul, South Korea

Location

GSK Investigational Site

San Juan, Spain

Location

GSK Investigational Site

Helsingborg, SE-252 78, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

GW406381X

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 19, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

NO(5)ES(1)SE(1)DK(1)KR(8)NL(3)