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Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Ibuprofen

Placebo

Celecoxib

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

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

Inclusion Criteria:

Inclusion criteria:

Aged >=40 years old
Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
Functional capacity class of I-III

Exclusion Criteria:

Exclusion criteria:

Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
Acute joint trauma at index joint within the past 3 months with active symptoms
Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
Use of mobility assisting device for <6 weeks or use of walker

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Secondary Outcome Measures

Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Change from baseline in patient and physician global assessments of arthritis

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

The Pain Satisfaction Scale

The Patient Health Questionnaire (PHQ-9)

Measurement of upper gastrointestinal tolerability

Adverse events

Laboratory test results

Vital signs

Physical examination

Full Information

NCT ID

NCT00630929

First Posted

February 28, 2008

Last Updated

February 18, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00630929

Brief Title

Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

Official Title

A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

388 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

800 mg oral tablet 3 times daily with meals for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matched placebo orally for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

200 mg oral capsule once daily with morning meal for 6 weeks

Primary Outcome Measure Information:

Title

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores

Time Frame

Days 1-7

Title

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale

Time Frame

Week 2

Title

Change from baseline in patient and physician global assessments of arthritis

Time Frame

Weeks 2 and 6

Title

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

Time Frame

Week 6

Title

The Pain Satisfaction Scale

Time Frame

Week 6

Title

The Patient Health Questionnaire (PHQ-9)

Time Frame

Week 6

Title

Measurement of upper gastrointestinal tolerability

Time Frame

Weeks 2 and 6

Title

Adverse events

Time Frame

Weeks 2 and 6

Title

Laboratory test results

Time Frame

Week 6

Title

Vital signs

Time Frame

Weeks 2 and 6

Title

Physical examination

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion criteria: Aged >=40 years old Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit Functional capacity class of I-III Exclusion Criteria: Exclusion criteria: Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded) Acute joint trauma at index joint within the past 3 months with active symptoms Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i Use of mobility assisting device for <6 weeks or use of walker

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Bad Muender

ZIP/Postal Code

31848

Country

Germany

Facility Name

Pfizer Investigational Site

City

Beckum

ZIP/Postal Code

59269

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10435

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10559

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12687

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ostseebad Damp

ZIP/Postal Code

24351

Country

Germany

Facility Name

Pfizer Investigational Site

City

Schwerin

ZIP/Postal Code

19057

Country

Germany

Facility Name

Pfizer Investigational Site

City

Stade

ZIP/Postal Code

21680

Country

Germany

Facility Name

Pfizer Investigational Site

City

Tostedt

ZIP/Postal Code

21255

Country

Germany

Facility Name

Pfizer Investigational Site

City

Weener

ZIP/Postal Code

26826

Country

Germany

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08029

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Pfizer Investigational Site

City

Cadiz

ZIP/Postal Code

11009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28035

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Pfizer Investigational Site

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Pfizer Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Chelmsly WOOD

State/Province

Birmingham

ZIP/Postal Code

B37 7TR

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Truro

State/Province

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Chorley

State/Province

Lancs

ZIP/Postal Code

PR7 1NY

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Liverpool

State/Province

Lancs

ZIP/Postal Code

L1 9AD

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Cannock

State/Province

Mid Staffordshire

ZIP/Postal Code

WS11 2XY

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Addlestone

State/Province

Surrey

ZIP/Postal Code

KT15 2BH

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Huddersfield

ZIP/Postal Code

HD3 3EA

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

NW3 2PF

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Manchester

ZIP/Postal Code

M41 5SL

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Wigan

ZIP/Postal Code

WN6 9EW

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28222627

Citation

Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191062&StudyName=Efficacy%20and%20Safety%20of%20Celecoxib%20versus%20Ibuprofen%20in%20the%20Treatment%20of%20Osteoarthritis%20of%20the%20Knee%20%28Europe%29

Description

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Learn more about this trial

Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

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Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

Osteoarthritis, Knee

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial