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    Summary
    EudraCT Number:2011-005115-82
    Sponsor's Protocol Code Number:C2011-0401
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-07
    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
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-005115-82
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.
    A.4.1Sponsor's protocol code numberC2011-0401
    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 SponsorSantarus, 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 supportSantarus Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSantarus, Inc.
    B.5.2Functional name of contact pointMichael Huang, MD, Medical Director
    B.5.3 Address:
    B.5.3.1Street Address3721 Valley Centre Drive, Suite 400
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858314 5772
    B.5.5Fax number+1 858 314 5701
    B.5.6E-mailmhuang@santarus.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 No
    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 nameBudesonide-MMX®
    D.3.4Pharmaceutical form Film coated gastro-resistant tablet
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 placeboFilm coated gastro-resistant tablet
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of UCDAI remission in patients with active, mild or moderate UC.
    E.2.2Secondary objectives of the trial
    -To compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of clinical remission in patients with active, mild or moderate UC.
    -To compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of endoscopic remission in patients with active, mild or moderate UC.
    - To compare the time to onset of clinical remission in the two treatment groups.
    - To compare the percentages of patients who achieve clinical improvement in the two treatment groups.
    - To compare the percentages of patients who achieve histologic healing in the two treatment groups.
    -To compare the percentages of treatment failures in the two treatment groups.
    - To evaluate the effects of budesonide MMX 9 mg on the inflammatory bowel disease-quality of life (IBD-QoL) questionnaire, CRP, and fecal calprotectin when compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with diagnosed UC fulfilling the following criteria at Screening are eligible for participation in the study:
    1. Age 18 to 75 years, inclusive
    2. Established diagnosis of UC, based on clinical history, exclusion of infectious causes (e.g., enteric bacterial infection, Clostridium difficile, parasites, ova, etc.), characteristic endoscopic findings, and histopathology results from biopsies.
    3. UC of mild or moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) score ≥ 4 and ≤ 10 according to Sutherland, with a mucosal appearance subscore of ≥ 1 and a physician’s rating of disease activity of 1 or 2.
    4. Currently experiencing active UC (flare) despite taking a therapeutic dose of an oral 5-ASA (e.g., mesalamine ≥ 2.4 g/day, or equivalent dose of another 5-ASA for a minimum of 6 weeks prior to randomization. At screening, photographic evidence of active UC based on mucosal appearance must be obtained from the flexible sigmoidoscopy procedure.
    5. Women of childbearing potential, or men of reproductive potential, must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate < 1% when properly applied and include: a combination oral pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be actively breast-feeding through the entire study period.
    6. Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and also able to comply with all requirements of the study. Must be able to understand and voluntarily sign a written informed consent prior to any study procedures.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria at Screening are to be excluded from study participation:
    1. Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).
    2. Patients with severe UC (UCDAI > 10 or PGA > 2), or patients not currently in an active phase or flare (defined in this study as a UCDAI score < 4).
    3. Patients with infectious colitis (based on positive microbiologic tests, Clostridium difficile toxin, or ova and parasites per the central laboratory) or any recent history of infectious colitis (within 30 days of Screening).
    4. Patients with a history of active malignancy or carcinoma in situ within the last 5 years (excised or treated non-melanoma skin cancers are not exclusionary).
    5. Patients with an active ulcer or bleeding disorder that may affect evaluation of blood in the stool.
    6. Evidence or history of toxic megacolon or bowel resection.
    7. Patients with Crohn’s disease or indeterminate colitis.
    8. Patients with a known hypersensitivity to budesonide or any of the ingredients of the budesonide MMX tablets
    9. Patients with active tuberculosis or any other active systemic or local bacterial, fungal, or viral infection.
    10. Patients with liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant impairment of the biohumoral parameters (≥ 2.5 x upper limit of normal [ULN] for ALT, AST, GGT, or ≥ 2 x ULN for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert’s syndrome are not exclusionary.
    11. Patients with severe diseases in other organs or systems.
    12. Patients with local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents.
    13. Patients diagnosed with type 1 diabetes.
    14.Patients diagnosed as having glaucoma, or with a family history of glaucoma in first degree relatives.
    15. Patients with known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to the local privacy policy.
    16. Patients with severe anemia (< 9 g/dL hemoglobin), leukopenia (< 2.5 x 109 white blood cells [WBC]/L), or granulocytopenia (< 1.2 x 109 cells/L).
    17. Patients with a history of pancolitis (disease that extends to the hepatic flexure or beyond) for ≥ 8 years or left-sided colitis (disease confined to the left colon [i.e., distal to the splenic flexure]) ≥ 15 years who have not yet completed a surveillance colonoscopy for dysplasia/colorectal cancer screening within the past year.
    18. Prior treatment with budesonide MMX.
    19. Use of oral corticosteroids including other budesonide formulations within the last 4 weeks prior to randomization.
    20. Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks prior to randomization.
    21. Use of immunosuppressive agents within the last 8 weeks prior to randomization.
    22. Use of anti-tumor necrosis factor-alpha (anti-TNFα) agents or other biologic therapies within the last 3 months prior to randomization.
    23. Participation in experimental therapeutic studies within the last 30 days prior to randomization (or within the last 3 months if in an anti-TNFα or biologic agent study). Note: patients who participated in observational-only studies (and who did not receive study therapy) are not excluded.
    24. Any other medical condition that in the Principal Investigator’s opinion would make the administration of the study drug or study procedures hazardous to the patient, or obscure the interpretation of adverse events (AEs) by the appropriate IEC/IRB.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is UCDAI (clinical and endoscopic) remission at Day 56, defined as a total UCDAI score (according to the Sutherland index of ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 56
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are as follows:
    • Clinical remission at Day 56, defined as a score of 0 for rectal bleeding and 0 for stool frequency from the UCDAI
    • Endoscopic remission at Day 56, defined as a score of 0 from the mucosal appearance subscore from the UCDAI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 56
    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) 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Czech Republic
    Hungary
    Poland
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months3
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 500
    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)
    Appropriate follow-up for ongoing safety concerns may consist of telephone follow-ups (for minor AEs), additional office visits (e.g., for re-assessment of glucocorticoid-related effects or other significant AEs), or additional laboratory tests (e.g., for abnormal plasma morning cortical/ACTH stimulation tests).
    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 Decision2012-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-02
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