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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2015-002558-11
    Sponsor's Protocol Code Number:000175
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-01
    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 ConcernedLatvia - SAM
    A.2EudraCT number2015-002558-11
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis
    A.4.1Sponsor's protocol code number000175
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02522780
    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 SponsorFerring International PharmaScience Center U.S., 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 supportFerring International PharmaScience Center U.S., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointClinical Development Support
    B.5.3 Address:
    B.5.3.1Street AddressInternational PharmaScience Center, Kay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen S
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.6E-mailDK0-Disclosure@ferring.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 Pentasa Compact 2g, granulate with prolonged release
    D.2.1.1.2Name of the Marketing Authorisation holderFerring B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Prolonged-release granules in sachet
    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 INNMESALAZINE
    D.3.9.1CAS number 89-57-6
    D.3.9.2Current sponsor codeFE 999907
    D.3.9.3Other descriptive nameMesalamine, 5-aminosalicylic acid [5-ASA]
    D.3.9.4EV Substance CodeSUB08782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboGranules
    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
    A bowel disease that is characterized by inflammation with ulcer formation in the lining of colon (large intestine)
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10058816
    E.1.2Term Colitis ulcerative acute episode
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of mesalamine 2 g extended release granules (sachet) once daily (QD) compared to placebo in the maintenance of remission of ulcerative colitis (UC)
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of mesalamine 2 g extended release granules (sachet) utilizing the Clinical and Endoscopic Response Score subsets, and frequency of treatment failures
    - To assess health-related quality of life
    - To assess the incidence and severity of adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Satisfied one of the following criteria for enrollment into the trial:
    a. Met the remission criteria at Week 8 of Study 000174 (Pathway 1) or
    b. Did not meet the remission criteria during Study 000174 and agreed to an additional 8 weeks of open-label treatment with mesalamine 4 g/day QD, after which met the remission criteria (Pathway 2) or
    c. Subjects not currently enrolled in Study 000174 and currently treated with medications for UC and currently in remission <1 year based on clinical and endoscopic evaluation (Clinical and Endoscopic Response Score of 0 or 1 and rectal bleeding and stool frequency scores of 0; i.e., clinical and endoscopic remission). The duration of prior remission must be less <1 year and include a history of flare (defined as escalation of medical therapy[ies]), and/or documented episode of recurrent rectal bleeding accompanied by abdominal pain and increased stool number that required medical intervention) (Pathway 3 – de novo)
    2. Signed informed consent obtained before any trial-related procedures
    3. Male or nonpregnant female subjects aged 18 to 75 years
    4. Extent of colonic involvement historically confirmed (i.e., flexible sigmoidoscopy/colonoscopy report, colonoscopy report, biopsy reading) within past 12 months
    5. Estimated creatinine clearance > 60 mL/min
    6. Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal
    intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Sterilized or postmenopausal women may also participate. Women must have a negative serum pregnancy test result at screening and negative urine pregnancy test result on baseline/randomization.
    E.4Principal exclusion criteria
    1. Evidence of other forms of inflammatory bowel disease
    2. Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
    3. Disease limited to proctitis <15 cm
    4. Short bowel syndrome
    5. Prior colon resection surgery
    6. History of severe/fulminant UC
    7. Intolerant or allergic to aspirin or salicylate derivatives
    8. Taking the following treatments:
    a. Aspirin within the past 7 days (except for cardioprotective reasons - maximum dose 325 mg/day)
    b. Loperamide and other antidiarrheal agents, mucilages, antibiotics (metronidazole and ciprofloxacin), nonsteroidal anti-inflammatory drugs (NSAIDs), nicotine patch within 1 week
    c. Corticosteroids (oral, intravenous, or intramuscular) within the previous month
    d. Immunomodulating/suppressing drugs within the previous 6 weeks
    e. Use of rectal formulations (5-ASA, steroids) within ≤7 days
    f. History of biologics (e.g., Remicade)
    9. Pathway 3 – de novo only: mesalamine use within 72 hours
    10. ALT; AST >3 x upper limit of normal (ULN)
    11. Clinically significant hematological function abnormalities
    12. Known alcohol or drug abuse
    13. Women who are pregnant or nursing
    14. History of or known malignancy (Note: Adequately treated (i.e. cured) basal cell carcinoma and cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years can be included)
    15. History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders that would interfere with participation in the trial
    16. Participation in a clinical trial with administration of another investigational medicinal product within the previous 30 days (except for Study 000174)
    17. Unable to comply with the requirements of the protocol
    18. Unable to complete the subject electronic diary or follow data-capturing procedures
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects in remission, defined by the Clinical and Endoscopic Response Score based
    on a modified 9 point Mayo Score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months
    E.5.2Secondary end point(s)
    1. The proportion of subjects in clinical remission at Months 2, 4, and 6
    2. Time to relapse, defined as number of days from randomization to the day of withdrawal due to escalation of therapy
    3. The change from baseline in the health-related quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated at pre-specified timepoints indicated in section E.5.2.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Belarus
    Belgium
    Bulgaria
    Canada
    Hungary
    Ireland
    Latvia
    Lithuania
    Mexico
    Russian Federation
    Serbia
    Switzerland
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 245
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 260
    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 will be treated according to local standard of care with no further follow-up to be conducted after their participation in the trial has completed.
    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 Decision2016-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-19
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 19:22:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA