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    Summary
    EudraCT Number:2006-002228-40
    Sponsor's Protocol Code Number:A3191193
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Not Authorised
    Date on which this record was first entered in the EudraCT database:2010-12-14
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2006-002228-40
    A.3Full title of the trial
    A PHASE III PLACEBO-CONTROLLED TRIAL OF CELECOXIB IN GENOTYPE POSITIVE SUBJECTS WITH FAMILIAL ADENOMATOUS POLYPOSIS
    A.3.2Name or abbreviated title of the trial where available
    CHIP
    A.4.1Sponsor's protocol code numberA3191193
    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 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 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 Yes
    D.2.1.1.1Trade name Onsenal
    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.3.1Product nameOnsenal (Celecoxib Oncology)
    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.3.10 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) 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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 2
    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 Onsenal
    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.3.1Product nameOnsenal (Celecoxib Oncology)
    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.3.10 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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 3
    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 Onsenal
    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.3.1Product nameOnsenal (Celecoxib Oncology)
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    D.3.11.8Extractive medicinal product No
    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
    D.8 Placebo: 2
    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
    GENOTYPE POSITIVE SUBJECTS WITH FAMILIAL ADENOMATOUS POLYPOSIS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10059327
    E.1.2Term Familial adenomatous polyposis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the time from randomization to treatment failure over a five year period for subjects treated with celecoxib versus subjects treated with placebo, where treatment failure is defined as the earliest occurrence of one or more of the following:
    a. Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study;
    OR
    b. Diagnosis of colorectal malignancy.
    E.2.2Secondary objectives of the trial
    • To compare the total number of polyps over 5 years for subjects treated with
    celecoxib versus subjects treated with placebo
    • To compare polyp burden over 5 years for subjects treated with celecoxib versus
    subjects treated with placebo
    • To compare the time to appearance of ≥ 5 colorectal adenomas for subjects treated
    with celecoxib versus subjects treated with placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A Pharmacokinetic sub-study (PK sites) is part of the main study
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Confirmed diagnosis of non-attenuated FAP based on central genetic testing
    2. Male or female subjects aged 10 to 17 years inclusive at the time of enrollment.
    3. Subject’s parent or legal guardian has provided written informed consent prior to enrollment in this study.
    4. Subject has assented to participate prior to enrollment in this study.
    5. Subject and parent/legal guardian, agree to comply with study requirements and are able to be at the clinic for all required study visits.
    6. Willingness to abstain from the chronic use of NSAIDs (including aspirin, selective COX-2 inhibitors), oral adrenocorticosteroids, and other non-steroidal OTC products for the duration of the study. Chronic use of NSAIDs is defined as a frequency of 1 week (7 consecutive days) for more than 3 weeks per year.
    7. If subject is female and of childbearing potential, she must meet all of the following
    conditions:• Have been using adequate contraception (eg, abstinence, condom, IUD,
    subdermal implant, birth control pill, diaphragm and spermicide foam/gel/cream/suppository combination) since her last menses; AND
    • Be willing to use adequate contraception (as above) during the study; AND
    • Not be breastfeeding; AND
    • Have a negative urine or serum pregnancy test within 14 days prior to study drug administration. If the central serum pregnancy test results are >14 days prior to study drug administration the test must be repeated. This will be done locally by either serum or urine testing.
    8. If subject is male and sexually active he must be willing to use a condom and be
    instructed that his female partner should be using adequate contraception (eg, female condom, IUD, sub dermal implant, birth control pill, diaphragm and spermicidal foam/gel/cream/suppository combination).
    9. The subject will be allowed to proceed to baseline colonoscopy so long as all of the following laboratory criteria (limits of normal for age as appropriate) are met on baseline evaluation:
    • Hemoglobin >10.0 gm/dl;
    • Platelet count >100,000/µl;
    • WBC >3,000/µl;
    • ALT <1.5 x upper limit of normal; AST <1.5 x upper limit of normal;
    • Alkaline Phosphatase <1.5 x upper limit of normal;
    • Total Bilirubin <1.5 x upper limit of normal unless the subject has Gilbert’s disease for which Total Bilirubin must be ≤2.0 x ULN;
    • Calculated Creatinine Clearance >90 mL/min/1.73 to the power of 2
    • No evidence of proteinuria or hematuria;
    • Cholesterol <1.5x upper limit of normal;
    • Microalbuminuria ≤23 mg/L;
    • For tests not mentioned specifically, there must be no clinically significant abnormalities that in the opinion of the PI would preclude a subject’s safe participation.
    10. Intact Colon.
    11. Colonoscopy will be performed at baseline according to the description provided in the Colonoscopy Procedures. To proceed to randomization, the subject must have all of the following:
    • An assessable colon endoscopically evaluated following an adequate bowel preparation AND
    • If <20 polyps (>2 mm in size), all must be removed so as to render the colon polyp-free and thus amenable to serial endoscopic surveillance.
    12. Systolic and Diastolic Blood Pressure <95th percentile. Those subjects with blood pressure measurements within the ≥90 to <95th percentile group are eligible for enrollment.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    -1. Diagnosis of attenuated FAP
    2. History of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs or salicylates
    3. Use of any dose of NSAIDs or oral adrenocorticosteroids, at any frequency of 3 or more times per week during the three months prior to study entry will require a three-month washout period beginning with the time of last dose. Use of any dose of NSAIDs or oral adrenocorticosteroids, at any frequency of less than 3 times per week during the three months prior to study entry will require a one-month washout period beginning with the time of last dose. If chronic inhaled steroid use is required, the subject agrees to use mometasone. Use of mometasone is not restricted. In countries were mometasone is not available, only fluticasone will be permitted
    4. Anticipated need for concurrent use of fluconazole or lithium
    5. Active peptic ulcer disease documented by endoscopy. Significant renal, hepatic or hematologic dysfunction (to be determined by investigator). History of H. pylori related peptic ulcer disease that has been successfully treated with antibiotics will not be exclusionary
    6. ≥20 polyps (> 2 mm without dye enhancement) at baseline colonoscopy
    7. < 20polyps(> 2 mm without dye enhancement) that have not all been removed at
    baseline colonoscopy
    8. Known inability to participate in the scheduled follow-up tests
    9. Significant medical or psychiatric problems, which, in the opinion of the site investigator, would make the subject a poor protocol candidate
    10. Subject has undergone a colectomy or planned to have colectomy within the next 6 months
    11. Subject has undergone chemotherapy within the past 6 months
    12. Subject has received pelvic radiation
    13. History of invasive carcinoma in the past five years
    14. Familial hypercholesterolemia
    15. Familial Hypertriglyceridemia
    16. Diabetes
    17. Coagulopathy
    18. Use of any investigational agent within the last 3 months
    19. ECG with any findings deemed by the investigator to be clinically significant.
    20. Subjects with Inflammatory Bowel Disease.
    21. Pre-existing renal disease such as glomerulonephritis, nephritic syndrome, renal
    transplants, or uncorrected renal/bladder obstruction.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is time to treatment failure defined as the time
    from randomization to the earliest occurrence of the following events:
    a. Appearance of ≥20 polyps (>2 mm in size) at any colonoscopy during the study;
    OR
    b. Diagnosis of colorectal malignancy.
    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 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) No
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    Study termination based on factors such as unacceptable adverse effects, lack of study drug efficacy, or poor accrual.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    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 Yes
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 200
    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)
    Subjects who develop ≥ 20 colorectal polyps or who develop < 20 colorectal polyps but cannot have all visible polyps (>2mm) removed, or who stop study drug for other reasons, will be followed annually off study treatment for up to 5 years, any subsequent colonoscopies and/or surgery as per standard of care.
    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 Decision2010-12-21
    N.Ethics Committee Opinion of the trial applicationNot-Favourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-29
    P. End of Trial
    P.End of Trial StatusNot Authorised
    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
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