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

NCT00807846 | Completed Phase 4 Results DMC

• 1 other identifier: A3191342
• Study Type: interventional
• Target: 201
• Locations: 10 countries
• Sites: 39

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

Conditions

Arthritis, Juvenile Rheumatoid

Keywords

Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit

  Value at 6 weeks minus value at baseline.

  6 Weeks/Final Visit

Secondary Outcomes (9)

• Change From Baseline to Week 2 in SBP.

  2 weeks

• Change From Baseline in SBP at Week 4.

  4 weeks

• Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.

  2 weeks

• Change From Baseline in DBP at Week 4.

  4 weeks

• Change From Baseline in DBP at Week 6/Final Visit

  6 weeks

Other Outcomes (4)

• Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit

  6 weeks/Final Visit

• Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit

  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)

  6 weeks/Final Visit

Study Arms (2)

Celecoxib

EXPERIMENTAL

Drug: Celecoxib

Naproxen

EXPERIMENTAL

Drug: Naproxen

Interventions

Celecoxib DRUG

Celecoxib 50 mg or 100 mg PO BID for 6 weeks

Celecoxib

Naproxen DRUG

Naproxen 7.5 mg/kg PO BID \[maximum of 500 mg BID\] for 6 weeks

Naproxen

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (39)

Catalina Pointe Clinical Research, Inc.

Tucson, Arizona, 85704, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Children's Hospital-San Diego

San Diego, California, 92123, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's National Medical Center / Division of Rheumatology

Washington D.C., District of Columbia, 20010, United States

Location

Arthritis Associates of South Florida

Delray Beach, Florida, 33484, United States

Location

Delray Research Associates

Delray Beach, Florida, 33484, United States

Location

Miami Children's Hospital

Miami, Florida, 33155-3009, United States

Location

Administrative Site-Hawaii Pacific Health Research Institute

Honolulu, Hawaii, 96813, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Kosair Charities Pediatric Clinical Research Unit - University of Louisville

Louisville, Kentucky, 40202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University Pediatric Rheumatology of Kentucky

Louisville, Kentucky, 40202, United States

Location

Children's Hospital and Medical Center

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center Pediatric Research Office

Omaha, Nebraska, 68198-5456, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital Regional de Concepcion Guillermo Grant Benavente

Concepción, Región del Biobío, 4070038, Chile

Location

Hospital Roberto del Rio

Santiago, RM, 8380418, Chile

Location

Instituto de Atencion Pediatrica

San José, 00000, Costa Rica

Location

Clinica San Borja/Centro de Investigacion de Reumatologia

San Borja, Lima region, L41, Peru

Location

Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia

San Isidro, Lima region, L27, Peru

Location

Philippine General Hospital

Manila, 1000, Philippines

Location

University of Santo Tomas Hospital

Manila, 1008, Philippines

Location

State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"

Moscow, 105077, Russia

Location

First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia

Moscow, 119992, Russia

Location

Smolensk Regional Clinical Hospital

Smolensk, 214000, Russia

Location

SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia

Smolensk, 214019, Russia

Location

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Children's Clinic of Internal Medicine

Niš, 18000, Serbia

Location

Clinical Research Unit

Pretoria, Gauteng, 0001, South Africa

Location

CHUV - Unit of Immuno-Allergology and Rhumatology

Ch-1011 Lausanne, Switzerland

Location

Universitaets-Kinderspital

Ch-8032 Zuerich, Switzerland

Location

Department of Cardioreumatology

Kharkiv, 61153, Ukraine

Location

Institute of Pediatrics, Obstetrics and Gynecology

Kiev, 04050, Ukraine

Location

Kyiv City Children Clinical Hospital #1

Kyiv, 04209, Ukraine

Location

Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases

Simferopol, 95034, Ukraine

Location

Zaporizhzhya Regional Clinical Pediatric Hospital

Zaporizhzhya, 69063, Ukraine

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Celecoxib; Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 12, 2008
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 2, 2021
• Results First Posted: November 11, 2015

Record last verified: 2021-01

Locations

CO (1); US (18); SE (2); CL (2); ZA (1); PH (2); UA (5); RU (4); CH (2); PE (2)