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

January 29, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile, 8380418
        • Hospital Roberto del Rio
    • VIII Region
      • Concepcion, VIII Region, Chile, 4070038
        • Hospital Regional de Concepcion Guillermo Grant Benavente
  • Costa Rica
      • San Jose, Costa Rica, 00000
        • Instituto de Atencion Pediatrica
  • Peru
    • Lima
      • San Borja, Lima, Peru, L41
        • Clinica San Borja/Centro de Investigacion de Reumatologia
      • San Isidro, Lima, Peru, L27
        • Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia
  • Philippines
      • Manila, Philippines, 1000
        • Philippine General Hospital
      • Manila, Philippines, 1008
        • University of Santo Tomas Hospital
  • Russian Federation
      • Moscow, Russian Federation, 105077
        • State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"
      • Moscow, Russian Federation, 119992
        • First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia
      • Smolensk, Russian Federation, 214000
        • Smolensk Regional Clinical Hospital
      • Smolensk, Russian Federation, 214019
        • SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Rheumatology
      • Nis, Serbia, 18000
        • Children's Clinic of Internal Medicine
  • South Africa
    • Gauteng Province
      • Pretoria, Gauteng Province, South Africa, 0001
        • Clinical Research Unit
  • Switzerland
      • Ch-1011 Lausanne, Switzerland
        • CHUV - Unit of Immuno-Allergology and Rhumatology
      • Ch-8032 Zuerich, Switzerland
        • Universitaets-Kinderspital
  • Ukraine
      • Kharkiv, Ukraine, 61153
        • Department of Cardioreumatology
      • Kiev, Ukraine, 04050
        • Institute of Pediatrics, Obstetrics and Gynecology
      • Kyiv, Ukraine, 04209
        • Kyiv City Children Clinical Hospital #1
      • Simferopol, Ukraine, 95034
        • Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases
      • Zaporizhzhya, Ukraine, 69063
        • Zaporizhzhya Regional Clinical Pediatric Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Catalina Pointe Clinical Research, Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • San Diego, California, United States, 92123
        • Children's Hospital-San Diego
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center / Division of Rheumatology
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Arthritis Associates of South Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Research Associates
      • Miami, Florida, United States, 33155-3009
        • Miami Children's Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96813
        • Administrative Site-Hawaii Pacific Health Research Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Kosair Children's Hospital
      • Louisville, Kentucky, United States, 40202
        • Kosair Charities Pediatric Clinical Research Unit - University of Louisville
      • Louisville, Kentucky, United States, 40202
        • University Pediatric Rheumatology of Kentucky
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital and Medical Center
      • Omaha, Nebraska, United States, 68198-5456
        • University of Nebraska Medical Center Pediatric Research Office
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naproxen
Drug: Naproxen
Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
Experimental: Celecoxib
Drug: Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Time Frame: 6 Weeks/Final Visit
Value at 6 weeks minus value at baseline.
6 Weeks/Final Visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 2 in SBP.
Time Frame: 2 weeks
Value at 2 weeks minus value at baseline.
2 weeks
Change From Baseline in SBP at Week 4.
Time Frame: 4 weeks
Value at 4 weeks minus value at baseline.
4 weeks
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Time Frame: 2 weeks
Value at 2 weeks minus value at baseline.
2 weeks
Change From Baseline in DBP at Week 4.
Time Frame: 4 weeks
Value at 4 weeks minus value at baseline.
4 weeks
Change From Baseline in DBP at Week 6/Final Visit
Time Frame: 6 weeks
Value at 6 weeks/Final Visit minus value at baseline.
6 weeks
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
Time Frame: 6 weeks
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.
6 weeks
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
Time Frame: 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.
Week 6/Final Visit
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Time Frame: 6 weeks
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'.
6 weeks
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Time Frame: 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'.
Week 6/Final Visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
Time Frame: 6 weeks/Final Visit
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.
6 weeks/Final Visit
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
Time Frame: 6 weeks/Final Visit
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.
6 weeks/Final Visit
Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
Time Frame: 6 weeks/Final Visit
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).
6 weeks/Final Visit
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
Time Frame: 6 weeks/Final Visit
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).
6 weeks/Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 12, 2008

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3191342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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