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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2005-004270-25
    Sponsor's Protocol Code Number:A3191173
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-19
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-004270-25
    A.3Full title of the trial
    Double-blind, parallel-group, randomized, study of the efficacy and safety of continuous use of celecoxib vs the “usual use” of celecoxib in the treatment of subjects with chronicosteoarthritis of the hip or knee who require an anti-inflammatory medication for control of their pain.
    A.4.1Sponsor's protocol code numberA3191173
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer S.A.
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Celebrex
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCelebrex
    D.3.2Product code SC-58635
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codeSC-58635
    D.3.9.3Other descriptive name4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoarthritis of knee or hip joint
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level VTc
    E.1.2Classification code 10031161
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether continuous use over a 6-month period of celecoxib 200 mg per day is more effective than intermittent use of celecoxib 200 mg per day in preventing spontaneous OA flares.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of continuous use over a 6-month period of celecoxib 200 mg QD versus “usual use” celecoxib 200 mg QD.
    2. To demonstrate whether disease management of OA as assessed by measures of pain and function is more effective using a regimen of celecoxib 200 mg QD continuous use over a 6-month period versus “usual use” celecoxib 200 mg QD.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects with diagnosed, active and symptomatic osteoarthritis of the hip and/or knee must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Subjects, male and female, aged 18-80 years old.
    2. Subject has been diagnosed according to the American College of Rheumatology (ACR) guidelines (Appendix D protocol) as having osteoarthritis of the knee or hip joint which the subject identifies as the index joint. Index joint must be in a native, non-prosthetic hip or knee joint.
    3. Subjects who, in the opinion of the investigator, may benefit from continuous NSAIDs to control their OA pain.
    4. Subjects need to have required NSAIDs to control OA pain within the past 1 month.
    5. Subjects must agree to keep physical activity at a stable level throughout the study.
    6. Subjects are willing to discontinue their NSAID and experience an OA flare.
    7. Subject is mentally and physically capable of performing all study related procedures including IVRS for up to approximately 26 weeks.
    8. Subject has access to a touch tone phone to use to contact the IVRS for the duration of the study.
    9. If the subject is female and of childbearing potential (including women who have been postmenopausal for less than two years) she must have been using adequate contraception since her last menses and is willing to use adequate contraception during the study, is not lactating, and has had a negative urine pregnancy test at Screening. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of run-in medication. Urine Pregnancy test may be repeated during the study (i.e. additional urine pregnancy tests in between visits) per IRB/EC request or if required by local regulations.
    10. Subjects taking up to 325 mg aspirin daily for cardiovascular prophylaxis and who have been on a stable dose for 30 days may be enrolled. Please note – if the subject does take aspirin for cardiovascular prophylaxis they must take the aspirin at least two hours prior to study drug dosingduring the course of the study.
    11. Screening flare of the index joint is demonstrated and resolved during the open label run-in with no reoccurrence of flare prior to Visit 3. Refer to Section 7.2 for the Criteria for Confirmation of Screening OA Flare and the Criteria for Resolution of Screening OA Flare.
    12. Subjects have signed and dated an informed consent document prior to undergoing any study procedures indicating that they have been informed of all pertinent aspects of the trial.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:1. History of rheumatoid arthritis.2. History of inflammatory arthritis or gout / pseudo-gout.3. Fibromyalgia Syndrome (FMS).4. Acute joint trauma at Index Joint within the past 3 months with active symptoms.5. Previous or anticipated need for surgical or other invasive procedure performed on index joint during the study6. Subject meets Class IV Criteria for Classification of Functional Capacity (Appendix I Protocol)7. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study8. Subjects have received oral (within 4 weeks), intramuscular (within 2 months), intraarticular (within 3 months) or soft-tissue (within 2 months) injections of corticosteroids, or intra-articular injections of hyaluronic acid in the Index Joint within 9 months of Visit 1 and throughout the duration of the study.9. Subject is currently taking or is anticipated to take any anticoagulants such as clopidogrel (low dose aspirin ≤ 325 mg daily is allowed) or lithium during the course of the study.10. Subject has an active malignancy or history of a malignancy (other then surgically removed basal cell carcinoma or cervical carcinoma in situ) within 5 years prior to enrollment in study.11. Subject has been diagnosed or treated for esophageal, gastric, pyloric channel or duodenal ulceration within 60 days prior to the first dose of study medication.12. Subject has a history of GI perforations, obstructions, or gastrointestinal bleeding.13. Subjects with active GI disease (e.g. inflammatory bowel disease or active peptic ulceration), a chronic or acute renal or hepatic disorder, and or a significant coagulation defect.14. Subjects with laboratory screening >1.5 ULN for SGOT, SGPT, estimated creatinine clearance less then 30 mL/min or other clinically significant lab abnormalities within 14 days of the Screening Visit.15. Subjects with known sensitivity to COX-2 specific inhibitors, paracetamol/acetaminophen, sulfonamides, aspirin, NSAIDS, or related compounds.16. Subjects on glucosamine and / or chondroitin sulfate are excluded unless they have been on a stable dose for greater than four months, or have discontinued these medications for at least four months.17. Subject has previously been screened for this study.18. Subject has symptoms, signs or treatment for congestive heart failure (NYHA Classification II-IV, Appendix H Protocol) or known left ventricular dysfunction with ejection fraction < 40%.19. The subject has established ischaemic heart disease and/or cerebrovascular disease.20. The subject has planned revascularization (PCI or CABG) at the time of study screening.21. The subject has atrial fibrillation or flutter, severe ventricular arrhythmias, or implantable cardioverter defibrillator (ICD).22. The subject has peripheral arterial disease.23. The subject has an unstable condition defined as any of the following:· Angina at rest or uncontrolled angina· Hospitalization or emergency department visits for cardiac-related illness in the previous 3 months.· Uncontrolled hypertension (defined as systolic BP >160 mmHg and/or diastolic BP >95 mmHg at the baseline visit).· The subject has undergone coronary by-pass surgery or any major surgery (cardiac or non-cardiac) or trauma within the previous 9 months.24. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and in the judgment of the investigator, would make the subject inappropriate for entry into this trial.25. Subjects who started physical therapy (including water aerobics) on the index joint less than six weeks prior to study screening26. Subjects who have been using a mobility assisting device such as a cane less than six weeks prior to study screening. Use of a walker assistive device is totally excluded.27. Pregnancy, or lactation; anticipated pregnancy during the study Period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the number of OA flares of the hip or knee joint which meet ACR criteria for OA from the first dose of study medication at the beginning of randomization to the last dose of study medication taken during Period III. OA flare is defined in Section 7.2 of Protocol.
    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 No
    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 Information not present in EudraCT
    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) No
    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 No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    NA
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 812
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
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