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A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

Primary Purpose

Arthritis, Juvenile Rheumatoid

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Celecoxib
Naproxen
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid focused on measuring Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
  • Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
  • ≥2 years of age and <18 years of age prior to the Baseline visit
  • Body weight ≥10 kg at the Baseline visit
  • Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

  • Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
  • Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
  • Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
  • Subjects with active Systemic JIA should not be enrolled

Sites / Locations

  • Catalina Pointe Clinical Research, Inc.
  • Arkansas Children's Hospital
  • Children's Hospital-San Diego
  • Connecticut Children's Medical Center
  • Children's National Medical Center / Division of Rheumatology
  • Arthritis Associates of South Florida
  • Delray Research Associates
  • Miami Children's Hospital
  • Administrative Site-Hawaii Pacific Health Research Institute
  • Kapiolani Medical Center for Women and Children
  • Kosair Charities Pediatric Clinical Research Unit - University of Louisville
  • Kosair Children's Hospital
  • University of Louisville
  • University Pediatric Rheumatology of Kentucky
  • Children's Hospital and Medical Center
  • University of Nebraska Medical Center Pediatric Research Office
  • Akron Children's Hospital
  • Milton S. Hershey Medical Center
  • Hospital Roberto del Rio
  • Hospital Regional de Concepcion Guillermo Grant Benavente
  • Instituto de Atencion Pediatrica
  • Clinica San Borja/Centro de Investigacion de Reumatologia
  • Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia
  • Philippine General Hospital
  • University of Santo Tomas Hospital
  • State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"
  • First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia
  • Smolensk Regional Clinical Hospital
  • SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia
  • Institute of Rheumatology
  • Children's Clinic of Internal Medicine
  • Clinical Research Unit
  • CHUV - Unit of Immuno-Allergology and Rhumatology
  • Universitaets-Kinderspital
  • Department of Cardioreumatology
  • Institute of Pediatrics, Obstetrics and Gynecology
  • Kyiv City Children Clinical Hospital #1
  • Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases
  • Zaporizhzhya Regional Clinical Pediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Celecoxib

Naproxen

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Value at 6 weeks minus value at baseline.

Secondary Outcome Measures

Change From Baseline to Week 2 in SBP.
Value at 2 weeks minus value at baseline.
Change From Baseline in SBP at Week 4.
Value at 4 weeks minus value at baseline.
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Value at 2 weeks minus value at baseline.
Change From Baseline in DBP at Week 4.
Value at 4 weeks minus value at baseline.
Change From Baseline in DBP at Week 6/Final Visit
Value at 6 weeks/Final Visit minus value at baseline.
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.

Full Information

First Posted
December 10, 2008
Last Updated
January 29, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00807846
Brief Title
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Official Title
A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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
Yes

5. Study Description

Brief Summary
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid
Keywords
Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Experimental
Arm Title
Naproxen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Description
Value at 6 weeks minus value at baseline.
Time Frame
6 Weeks/Final Visit
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 2 in SBP.
Description
Value at 2 weeks minus value at baseline.
Time Frame
2 weeks
Title
Change From Baseline in SBP at Week 4.
Description
Value at 4 weeks minus value at baseline.
Time Frame
4 weeks
Title
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Description
Value at 2 weeks minus value at baseline.
Time Frame
2 weeks
Title
Change From Baseline in DBP at Week 4.
Description
Value at 4 weeks minus value at baseline.
Time Frame
4 weeks
Title
Change From Baseline in DBP at Week 6/Final Visit
Description
Value at 6 weeks/Final Visit minus value at baseline.
Time Frame
6 weeks
Title
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
Description
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Time Frame
6 weeks
Title
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
Description
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Time Frame
Week 6/Final Visit
Title
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Description
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Time Frame
6 weeks
Title
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Description
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Time Frame
Week 6/Final Visit
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
Description
Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.
Time Frame
6 weeks/Final Visit
Title
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
Description
Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.
Time Frame
6 weeks/Final Visit
Title
Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
Description
A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).
Time Frame
6 weeks/Final Visit
Title
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
Description
A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).
Time Frame
6 weeks/Final Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA) Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible ≥2 years of age and <18 years of age prior to the Baseline visit Body weight ≥10 kg at the Baseline visit Candidate for chronic NSAID therapy in the Investigator's judgment Exclusion Criteria: Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA) Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded Subjects with active Systemic JIA should not be enrolled
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
Catalina Pointe Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital-San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Children's National Medical Center / Division of Rheumatology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Arthritis Associates of South Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Delray Research Associates
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-3009
Country
United States
Facility Name
Administrative Site-Hawaii Pacific Health Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit - University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Pediatric Rheumatology of Kentucky
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Children's Hospital and Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center Pediatric Research Office
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5456
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital Roberto del Rio
City
Santiago
State/Province
RM
ZIP/Postal Code
8380418
Country
Chile
Facility Name
Hospital Regional de Concepcion Guillermo Grant Benavente
City
Concepcion
State/Province
VIII Region
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Instituto de Atencion Pediatrica
City
San Jose
ZIP/Postal Code
00000
Country
Costa Rica
Facility Name
Clinica San Borja/Centro de Investigacion de Reumatologia
City
San Borja
State/Province
Lima
ZIP/Postal Code
L41
Country
Peru
Facility Name
Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia
City
San Isidro
State/Province
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
University of Santo Tomas Hospital
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214000
Country
Russian Federation
Facility Name
SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Children's Clinic of Internal Medicine
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Clinical Research Unit
City
Pretoria
State/Province
Gauteng Province
ZIP/Postal Code
0001
Country
South Africa
Facility Name
CHUV - Unit of Immuno-Allergology and Rhumatology
City
Ch-1011 Lausanne
Country
Switzerland
Facility Name
Universitaets-Kinderspital
City
Ch-8032 Zuerich
Country
Switzerland
Facility Name
Department of Cardioreumatology
City
Kharkiv
ZIP/Postal Code
61153
Country
Ukraine
Facility Name
Institute of Pediatrics, Obstetrics and Gynecology
City
Kiev
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Kyiv City Children Clinical Hospital #1
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases
City
Simferopol
ZIP/Postal Code
95034
Country
Ukraine
Facility Name
Zaporizhzhya Regional Clinical Pediatric Hospital
City
Zaporizhzhya
ZIP/Postal Code
69063
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191342&StudyName=A%20Study%20To%20Evaluate%20The%20Effects%20Of%20Celecoxib%20%28Celebrex%AE%29%20Or%20Naproxen%20On%20Blood%20Pressure%20In%20Pediatric%20Subjects
Description
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A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

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