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A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Primary Purpose

Arthritis, Juvenile Rheumatoid

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Celecoxib
Celecoxib
Naproxen
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid focused on measuring arthritis, juvenile

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

High Dose

Low Dose

Naproxen

Arm Description

Control comparator, 15 mg/kg/dy target dose

Outcomes

Primary Outcome Measures

ACR Pediatric 30

Secondary Outcome Measures

Peds QOL
composites of acr 30

Full Information

First Posted
April 1, 2008
Last Updated
May 29, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00652925
Brief Title
A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
Official Title
Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid
Keywords
arthritis, juvenile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose
Arm Type
Experimental
Arm Title
Low Dose
Arm Type
Experimental
Arm Title
Naproxen
Arm Type
Active Comparator
Arm Description
Control comparator, 15 mg/kg/dy target dose
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Higher dose, 6 mg/kg/dose BID
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Active drug at lower dose
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Control comparator, 15 mg/kg/dy target dose
Primary Outcome Measure Information:
Title
ACR Pediatric 30
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Peds QOL
Time Frame
12 weeks
Title
composites of acr 30
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 2-18 years old with active JRA Exclusion Criteria: other experimental meds, recent changes in arthritis meds
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
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Pfizer Investigational Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60649
Country
United States
Facility Name
Pfizer Investigational Site
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Pfizer Investigational Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Pfizer Investigational Site
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pfizer Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Facility Name
Pfizer Investigational Site
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Pfizer Investigational Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Pfizer Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1623
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Pfizer Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Pfizer Investigational Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Pfizer Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pfizer Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Pfizer Investigational Site
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Pfizer Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-0509
Country
United States
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
20551-030
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04025-002
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-901
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
21944-970
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Pfizer Investigational Site
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
Pfizer Investigational Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Guadalajara
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L05
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L13
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L31
Country
Peru
Facility Name
Pfizer Investigational Site
City
Vila Nova de Famalicao
ZIP/Postal Code
4764-901
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119296
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=N49-01-02-195&StudyName=Randomized%2C%20Double-Blind%2C%20Multicenter%2C%20Active%20Controlled%20Parallel%20Group%20Study%20to%20Evaluate%20the%20Efficacy%20and%20Safety%20of%20Celecoxib%20Susp
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

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