A Study of GW842166 in Adults With Osteoarthritis Pain | NCT00447486

Studies
A Study of GW842166 in Adults With Osteoarthritis Pain

NCT00447486

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 18, 2009Estimated

Enrollment

308Actual

Phase

Phase 2

Conditions

Osteoarthritis, Knee

Interventions

GW842166

Countries

Denmark
Germany
Spain
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2009

Last Update Posted Date

May 18, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Name	Type	Description	Arm Group Labels	Other Names
GW842166	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline		4 Weeks

Secondary Outcomes

Measure	Description	Time Frame
WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments		4 Weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials, BSc MB PhD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Hvidovre		2650	Denmark
GSK Investigational Site

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis
D010146	Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided