Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39211   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-003737-26
    Sponsor's Protocol Code Number:A3191342
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-003737-26
    A.3Full title of the trial
    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 paediatric subjects with juvenile idiopathic arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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 paediatric subjects with juvenile idiopathic arthritis
    A.4.1Sponsor's protocol code numberA3191342
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00807846
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Celebrex
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/070
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCelecoxib
    D.3.9.1CAS number 169590-42-5
    D.3.9.3Other descriptive nameCELECOXIB
    D.3.9.4EV Substance CodeSUB01143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCelecoxib
    D.3.9.1CAS number 169590-42-5
    D.3.9.3Other descriptive nameCELECOXIB
    D.3.9.4EV Substance CodeSUB01143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNaproxen
    D.3.4Pharmaceutical form Suspension and effervescent granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNAPROXEN SODIUM
    D.3.9.1CAS number 22204-53-1
    D.3.9.4EV Substance CodeSUB03392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension and effervescent granules for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile idiopathic arthritis
    E.1.1.1Medical condition in easily understood language
    Inflammatory disorder of joints in children
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of treatment with celecoxib on systolic blood pressure (SBP) compared to treatment with naproxen in subjects with JIA (oligoarticular, polyarticular arthritis and children with systemic onset disease but inactive systemic features).
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of treatment with celecoxib on diastolic blood pressure (DBP) compared to treatment with naproxen in subjects with JIA
    2. To evaluate adverse event profile and gastrointestinal (GI) tolerability of treatment with celecoxib versus (vs.) treatment with naproxen in subjects with JIA
    3. To evaluate the effect of treatment with celecoxib on Parent’s and Subject’s Global Assessment of Overall Well-Being compared to treatment with naproxen in subjects with JIA
    4. To evaluate the effect of celecoxib and naproxen on BP measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study (Exploratory Analysis) for 24-Hour Ambulatory Blood Pressure Monitoring (24-hours ABPM) in Subjects with JIA
    E.3Principal inclusion criteria
    1. Polyarticular (both rheumatoid factor positive and rheumatoid factor negative), oligoarticular and extended oligoarticular JIA for greater than or equal to (>=) 3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for JIA. Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible. Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded.
    2. >=2 years of age and less than (<) 18 years of age prior to the Baseline visit.
    3. Body weight >=10 kg at the Baseline visit.
    4. Candidate for chronic Non-steroidal anti-inflammatory drug (NSAID) therapy in the Investigator’s judgment.
    5. Females of childbearing potential (defined as menarche or >=10 years of age, whichever occurs sooner) must agree to use adequate contraception (adequate contraception can include abstinence if the Investigator deems appropriate) and must have a negative urine pregnancy test prior to administration of study medication.
    6. Subject’s parent or legal guardian has provided written informed consent document prior to enrollment in this study.
    E.4Principal exclusion criteria
    1. Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
    2. Active systemic features over the prior 12 weeks in children with systemic JIA.
    3. Subjects taking any of the following medications are specifically excluded:
    4. Current NSAID or salicylate compounds (must be discontinued more than (>)5 half-lives, or a minimum of 48 hours, whichever is greater, prior to the Baseline Visit).
    5. Anticoagulants (eg, warfarin, heparin, low molecular weight heparin);
    • Lithium;
    • Cyclosporine;
    • Tacrolimus (FK 506);
    • Antihypertensives;
    • Any medication in the investigator judgment which will affect the blood pressure;
    6. Any investigational medication within 30 days prior to Screening or subject is scheduled to receive an investigational drug during the course of this study.
    7. Initiation of or the change in doses of disease modifying anti-rheumatic drugs
    8. (DMARDs) and / or Biologics within 30 days of Screening.
    9. Oral or injectable (including intra-articular) corticosteroids administered within
    10. 2 weeks of Screening/Baseline. Subjects are allowed to continue intranasal or
    11. orally-inhaled corticosteroids provided they have been at a stable dose for at least 30 days prior to Screening/Baseline and the dose is not expected to change during the duration of the study.
    12. Known hypersensitivity allergy or hypersensitivity to sulfonamides, COX-2 selective inhibitors (including celecoxib), aspirin or NSAIDS (including naproxen). Subjects who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs must be excluded.
    13. Diagnosis of or received treatment for esophageal, gastric, pyloric channel, or
    14. duodenal ulceration within 60 days of Screening.
    15. Active GI disease (eg, inflammatory bowel disease, Crohn’s disease, ulcerative
    16. colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any condition that in the Investigator’s opinion might preclude the use of an NSAID.
    17. AST /glutamic oxaloacetate transaminase (SGOT), ALT/Serum glutamic pyruvate transaminase (SGPT), Creatinine or Blood urea nitrogen (BUN) > 1.5* upper limit of normal (ULN) for age/gender-adjusted normal values as per the central laboratory, or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days prior to Baseline.
    18. Hypertension defined as Systolic blood pressure(SBP) and/or Diastolic Blood pressure (DBP) values >= 95th percentile for the subject’s age, gender, and height (according to the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children Adolescents for 3 measures at the Baseline visit. If the subject’s medical history indicates that the subject is normotensive, the subjects can be rescreened during the 2-week Screening period to determine if the subject is suitable for the study. Subjects currently treated with antihypertensive medication(s) are not eligible for the study.
    19. Active malignancy of any type or history of a malignancy. (Subjects with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence in the prior 2 years and at the time of Screening are acceptable).
    20. Any significant, uncontrolled chronic condition (eg, diabetes, epilepsy, psychiatric disorders), or any other condition which, in the opinion of the Investigator, would contraindicate study participation or confound interpretation of the results.
    21. Plans for surgical intervention during the course of the study.
    22. Participated previously in this study.Unlikely to be compliant with study procedures, including calm participation inBP assessments.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 6/Final visit in Systolic Blood Pressure at Week 6/Final visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 6
    E.5.2Secondary end point(s)
    1) Change from Baseline in SBP at Week 2 and 4
    2) Change from Baseline in DBP at Week 2, 4, and 6/Final visit
    3) Change from Baseline in Parent's and Subject's Assessment of Overall Well-Being at Week 6/Final visit
    4) Number of subjects with >=30% improvement in the Parent’s Global Assessment of Overall Well-Being
    5) Systolic and diastolic blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM)
    6) Number of subjects with treatment-emergent adverse events and serious adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline, Week 2, 4
    2) Baseline, Week 2, 4, 6
    3) Baseline, Week 2, 4, 6
    4) Week 6
    5) Baseline, Week 6
    6) Baseline up to 28 days after last dose
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Chile
    Costa Rica
    Peru
    Philippines
    Russian Federation
    Serbia
    South Africa
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 198
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 96
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 102
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    >=2 years of age and <18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 201
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA