---
title: A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
nct_id: NCT00807846
overall_status: COMPLETED
phase: PHASE4
sponsor: "Pfizer's Upjohn has merged with Mylan to form Viatris Inc."
study_type: INTERVENTIONAL
primary_condition: Arthritis, Juvenile Rheumatoid
countries: United States, Chile, Costa Rica, Peru, Philippines, Russia, Serbia, South Africa, Switzerland, Ukraine
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00807846.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00807846"
ct_last_update_post_date: 2021-02-02
last_seen_at: "2026-05-12T06:14:51.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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.

**NCT ID:** [NCT00807846](https://clinicaltrials.gov/study/NCT00807846)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 201
- **Lead Sponsor:** Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- **Conditions:** Arthritis, Juvenile Rheumatoid
- **Start Date:** 2009-09
- **Completion Date:** 2012-12
- **CT.gov Last Update:** 2021-02-02

## 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

## Eligibility

- **Minimum age:** 2 Years
- **Maximum age:** 17 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Celecoxib** (EXPERIMENTAL)
- **Naproxen** (EXPERIMENTAL)

## Interventions

- **Celecoxib** (DRUG) — Celecoxib 50 mg or 100 mg PO BID for 6 weeks
- **Naproxen** (DRUG) — Naproxen 7.5 mg/kg PO BID \[maximum of 500 mg BID\] for 6 weeks

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Change From Baseline to Week 2 in SBP.** _(time frame: 2 weeks)_
- **Change From Baseline in SBP at Week 4.** _(time frame: 4 weeks)_
- **Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.** _(time frame: 2 weeks)_
- **Change From Baseline in DBP at Week 4.** _(time frame: 4 weeks)_
- **Change From Baseline in DBP at Week 6/Final Visit** _(time frame: 6 weeks)_
- **Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.** _(time frame: 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)_
- **Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.** _(time frame: 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)_

## Locations (39)

- Catalina Pointe Clinical Research, Inc., Tucson, Arizona, United States
- Arkansas Children's Hospital, Little Rock, Arkansas, United States
- Children's Hospital-San Diego, San Diego, California, United States
- Connecticut Children's Medical Center, Hartford, Connecticut, United States
- Children's National Medical Center / Division of Rheumatology, Washington D.C., District of Columbia, United States
- Arthritis Associates of South Florida, Delray Beach, Florida, United States
- Delray Research Associates, Delray Beach, Florida, United States
- Miami Children's Hospital, Miami, Florida, United States
- Administrative Site-Hawaii Pacific Health Research Institute, Honolulu, Hawaii, United States
- Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
- Kosair Charities Pediatric Clinical Research Unit - University of Louisville, Louisville, Kentucky, United States
- Kosair Children's Hospital, Louisville, Kentucky, United States
- University of Louisville, Louisville, Kentucky, United States
- University Pediatric Rheumatology of Kentucky, Louisville, Kentucky, United States
- Children's Hospital and Medical Center, Omaha, Nebraska, United States
- University of Nebraska Medical Center Pediatric Research Office, Omaha, Nebraska, United States
- Akron Children's Hospital, Akron, Ohio, United States
- Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
- Hospital Regional de Concepcion Guillermo Grant Benavente, Concepción, Biobio, Chile
- Hospital Roberto del Rio, Santiago, RM, Chile
- Instituto de Atencion Pediatrica, San José, Costa Rica
- Clinica San Borja/Centro de Investigacion de Reumatologia, San Borja, Lima region, Peru
- Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia, San Isidro, Lima region, Peru
- Philippine General Hospital, Manila, Philippines
- University of Santo Tomas Hospital, Manila, Philippines
- State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital", Moscow, Russia
- First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia, Moscow, Russia
- Smolensk Regional Clinical Hospital, Smolensk, Russia
- SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia, Smolensk, Russia
- Institute of Rheumatology, Belgrade, Serbia
- Children's Clinic of Internal Medicine, Niš, Serbia
- Clinical Research Unit, Pretoria, Gauteng, South Africa
- CHUV - Unit of Immuno-Allergology and Rhumatology, Ch-1011 Lausanne, Switzerland
- Universitaets-Kinderspital, Ch-8032 Zuerich, Switzerland
- Department of Cardioreumatology, Kharkiv, Ukraine
- Institute of Pediatrics, Obstetrics and Gynecology, Kiev, Ukraine
- Kyiv City Children Clinical Hospital #1, Kyiv, Ukraine
- Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases, Simferopol, Ukraine
- Zaporizhzhya Regional Clinical Pediatric Hospital, Zaporizhzhya, Ukraine

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.catalina pointe clinical research, inc.|tucson|arizona|united states` — added _(2026-05-12)_
- `locations.arkansas children's hospital|little rock|arkansas|united states` — added _(2026-05-12)_
- `locations.children's hospital-san diego|san diego|california|united states` — added _(2026-05-12)_
- `locations.connecticut children's medical center|hartford|connecticut|united states` — added _(2026-05-12)_
- `locations.children's national medical center / division of rheumatology|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.arthritis associates of south florida|delray beach|florida|united states` — added _(2026-05-12)_
- `locations.delray research associates|delray beach|florida|united states` — added _(2026-05-12)_
- `locations.miami children's hospital|miami|florida|united states` — added _(2026-05-12)_
- `locations.administrative site-hawaii pacific health research institute|honolulu|hawaii|united states` — added _(2026-05-12)_
- `locations.kapiolani medical center for women and children|honolulu|hawaii|united states` — added _(2026-05-12)_
- `locations.kosair charities pediatric clinical research unit - university of louisville|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.kosair children's hospital|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.university of louisville|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.university pediatric rheumatology of kentucky|louisville|kentucky|united states` — added _(2026-05-12)_
- `locations.children's hospital and medical center|omaha|nebraska|united states` — added _(2026-05-12)_
- `locations.university of nebraska medical center pediatric research office|omaha|nebraska|united states` — added _(2026-05-12)_
- `locations.akron children's hospital|akron|ohio|united states` — added _(2026-05-12)_
- `locations.milton s. hershey medical center|hershey|pennsylvania|united states` — added _(2026-05-12)_
- `locations.hospital regional de concepcion guillermo grant benavente|concepción|biobio|chile` — added _(2026-05-12)_
- `locations.hospital roberto del rio|santiago|rm|chile` — added _(2026-05-12)_
- `locations.instituto de atencion pediatrica|san josé||costa rica` — added _(2026-05-12)_
- `locations.clinica san borja/centro de investigacion de reumatologia|san borja|lima region|peru` — added _(2026-05-12)_
- `locations.clinica ricardo palma/sitio de investigacion de reumatologia|san isidro|lima region|peru` — added _(2026-05-12)_
- `locations.philippine general hospital|manila||philippines` — added _(2026-05-12)_
- `locations.university of santo tomas hospital|manila||philippines` — added _(2026-05-12)_
- `locations.state healthcare institution of moscow "izmailovskaya city children's hospital"|moscow||russia` — added _(2026-05-12)_
- `locations.first moscow state medical university i.m. sechenov of the minzdravsocrazvitiya of russia|moscow||russia` — added _(2026-05-12)_
- `locations.smolensk regional clinical hospital|smolensk||russia` — added _(2026-05-12)_
- `locations.seihpe "smolensk state medical academy"of the minzdravsocrazvitiya of russia|smolensk||russia` — added _(2026-05-12)_
- `locations.institute of rheumatology|belgrade||serbia` — added _(2026-05-12)_
- `locations.children's clinic of internal medicine|niš||serbia` — added _(2026-05-12)_
- `locations.clinical research unit|pretoria|gauteng|south africa` — added _(2026-05-12)_
- `locations.chuv - unit of immuno-allergology and rhumatology|ch-1011 lausanne||switzerland` — added _(2026-05-12)_
- `locations.universitaets-kinderspital|ch-8032 zuerich||switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00807846.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00807846*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*