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

Arthritis, Juvenile Rheumatoid Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807846
• Other study ID #: A3191342
• Status: Completed
• Phase: Phase 4
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Rheumatoid

Intervention

Drug:
• Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
• Naproxen
Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks

Locations

Country	Name	City	State
Chile	Hospital Regional de Concepcion Guillermo Grant Benavente	Concepcion	VIII Region
Chile	Hospital Roberto del Rio	Santiago	RM
Costa Rica	Instituto de Atencion Pediatrica	San Jose
Peru	Clinica San Borja/Centro de Investigacion de Reumatologia	San Borja	Lima
Peru	Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia	San Isidro	Lima
Philippines	Philippine General Hospital	Manila
Philippines	University of Santo Tomas Hospital	Manila
Russian Federation	First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia	Moscow
Russian Federation	State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"	Moscow
Russian Federation	SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia	Smolensk
Russian Federation	Smolensk Regional Clinical Hospital	Smolensk
Serbia	Institute of Rheumatology	Belgrade
Serbia	Children's Clinic of Internal Medicine	Nis
South Africa	Clinical Research Unit	Pretoria	Gauteng Province
Switzerland	CHUV - Unit of Immuno-Allergology and Rhumatology	Ch-1011 Lausanne
Switzerland	Universitaets-Kinderspital	Ch-8032 Zuerich
Ukraine	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
United States	Akron Children's Hospital	Akron	Ohio
United States	Arthritis Associates of South Florida	Delray Beach	Florida
United States	Delray Research Associates	Delray Beach	Florida
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Administrative Site-Hawaii Pacific Health Research Institute	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Arkansas Children's Hospital	Little Rock	Arkansas
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	Miami Children's Hospital	Miami	Florida
United States	Children's Hospital and Medical Center	Omaha	Nebraska
United States	University of Nebraska Medical Center Pediatric Research Office	Omaha	Nebraska
United States	Children's Hospital-San Diego	San Diego	California
United States	Catalina Pointe Clinical Research, Inc.	Tucson	Arizona
United States	Children's National Medical Center / Division of Rheumatology	Washington	District of Columbia

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Chile,  Costa Rica,  Peru,  Philippines,  Russian Federation,  Serbia,  South Africa,  Switzerland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/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
Other	Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/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
Other	Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)	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
Other	Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)	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
Primary	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	Change From Baseline to Week 2 in SBP.	Value at 2 weeks minus value at baseline.	2 weeks
Secondary	Change From Baseline in SBP at Week 4.	Value at 4 weeks minus value at baseline.	4 weeks
Secondary	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.	Value at 2 weeks minus value at baseline.	2 weeks
Secondary	Change From Baseline in DBP at Week 4.	Value at 4 weeks minus value at baseline.	4 weeks
Secondary	Change From Baseline in DBP at Week 6/Final Visit	Value at 6 weeks/Final Visit minus value at baseline.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	Week 6/Final Visit
Secondary	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'.	6 weeks
Secondary	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'.	Week 6/Final Visit

External Links

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