Effectiveness Of Single Doses Of Ibuprofen In Patients Wi... | NCT00372801

Studies
Effectiveness Of Single Doses Of Ibuprofen In Patients With Osteoarthritis Of The Knee

NCT00372801

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

Phase

Phase 1

Conditions

Osteoarthritis

Interventions

Ibuprofen

Countries

Australia

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

Oct 2008

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

Aug 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 5, 2006

First Submission Date that Met QC Criteria

Sep 5, 2006

First Posted Date

Sep 7, 2006Estimated

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

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Description Module

Brief Summary

To demonstrate that new drugs work, many complex multidose studies are often required. The intent of this study is to use Ibuprofen as an example of a marketed pain relief drug to validate a simpler single dose model for future assessment of new pain drugs.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity recorded over 0-8 hours using question 1 of the WOMAC (Western Ontario and McMaster University Osteoarthritis Index)pain subscale (visual analog scale).

Secondary Outcomes

Measure	Description	Time Frame
Responder rate Patient impression of change - 8 & 24 hrs post dose Time to use of rescue medication (paracetamol)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Subjects diagnosed with primary Osteoarthritis of the knee.
Have at least 3 months in symptom duration prior to screening visit.
Regular user of a prescribed non-steroidal anti-inflammatory drug (NSAID) or selective cyclo-oxygenase II (COX2) inhibitor for management of knee pain.
Pain walking on flat surface within specific interval prior to study start.

Exclusion criteria:

History of hypersensitivity to NSAIDS.
Allergy to Ibuprofen.
Use of assistive devices other than a cane or knee brace.
History of specified diseases/illnesses.
Abnormal blood tests pre-study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Randwick, Sydney	New South Wales	2031	Australia

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007052	Ibuprofen

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided