Official title: Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

Conditions: Arthritis, Juvenile Rheumatoid
Being tested: Celecoxib, Naproxen
Keywords: arthritis, juvenile
Medical subject headings: Arthritis, Juvenile, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
Higher dose, 6 mg/kg/dose BID
CelecoxibDrug
Active drug at lower dose
NaproxenDrug
Control comparator, 15 mg/kg/dy target dose

Study groups in NCT00652925
Study group	Role	What they receive
High Dose	Experimental	Not described Receives: Drug: Celecoxib
Low Dose	Experimental	Not described Receives: Drug: Celecoxib
Naproxen	Active comparator	Control comparator, 15 mg/kg/dy target dose Receives: Drug: Naproxen

What is being measured

The primary outcome is the main question the study is designed to answer.

ACR Pediatric 30
Measured: 12 weeks

Secondary outcomes (2)

Peds QOL
Measured: 12 weeks
composites of acr 30
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2002Apr 2005

First posted4 Apr 2008 (estimated)
Study startOct 2002
Primary completionApr 2004
Study completionApr 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00652925
Sponsor's protocol ID: N49-01-02-195
Other IDs: A3191127
Status last verified: Apr 2008
First submitted: 1 Apr 2008
Last updated: 30 May 2008
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
RecruitingObservational study
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 3
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
Systemic Lupus Erythematosus, Sjögren's Disease
Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy

All Arthritis, Juvenile Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
ClinicalTrials.gov ID: NCT00652925
Acronym / sponsor ID: N49-01-02-195
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: arthritis, juvenile
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2002
Primary completion: Apr 2004 (actual)
Study completion: Apr 2005 (actual)
First posted: 4 Apr 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
High Dose	Experimental	Drug: Celecoxib
Low Dose	Experimental	Drug: Celecoxib
Naproxen	Active comparator	Drug: NaproxenControl comparator, 15 mg/kg/dy target dose

Who may qualify

Ages: 2 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

2-18 years old with active JRA

Key exclusion criteria (1 listed)

other experimental meds, recent changes in arthritis meds

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CelecoxibHigher dose, 6 mg/kg/dose BID	Drug	High Dose
CelecoxibActive drug at lower dose	Drug	Low Dose
NaproxenControl comparator, 15 mg/kg/dy target dose	Drug	Naproxen

Primary outcome

ACR Pediatric 30
Time frame: 12 weeks

2 secondary outcomes

Peds QOL
Time frame: 12 weeks
composites of acr 30
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Arthritis, Juvenile Rheumatoid

RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
RecruitingObservational study
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Not yet recruitingPhase 3
Continued Access to Deucravacitinib for Adult SLE/SjD and Pediatric PsO/PsA Study Completers
Systemic Lupus Erythematosus, Sjögren's Disease
Not yet recruitingObservational study
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
Pericarditis, Tako-TSUBO Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

58 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib and Naproxen in people with Arthritis, Juvenile Rheumatoid, run by Pfizer at 58 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Germany, Brazil, Peru, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR Pediatric 30 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00652925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2008.