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    Summary
    EudraCT Number:2010-020906-14
    Sponsor's Protocol Code Number:50591903
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-17
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-020906-14
    A.3Full title of the trial
    Randomized controlled trial of escitalopram versus placebo for patients with irritable bowel syndrome and panic disorder.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation on the efficacy of treatment of patients with functional abdominal pain and anxiety disorder with escitalopram, compared to placebo.
    A.3.2Name or abbreviated title of the trial where available
    escitalopram trial
    A.4.1Sponsor's protocol code number50591903
    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 SponsorMUMC
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMUMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMUMC
    B.5.2Functional name of contact pointClinical Trial Center Maastricht
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 HX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031433872059
    B.5.5Fax number0031433872044
    B.5.6E-mailf.hameleers@mumc.nl
    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 escitalopram
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck
    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.3.1Product nameEscitalopram
    D.3.2Product code NL/H/0984/001
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameEscitalopram
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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 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 escitalopram
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck
    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.3.1Product nameEscitalopram
    D.3.2Product code NL/H/0984/001
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameEscitalopram
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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 placeboTablet
    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
    IBS and panic disorder
    E.1.1.1Medical condition in easily understood language
    Functional abdominal pain and anxiety disorder
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Efficacy of Escitalopram vs placebo in the treatment of IBS patients with panic disorder
    E.2.2Secondary objectives of the trial
    - effect of Escitalopram on gastrointestinal and psychiatric symptoms
    - effect of Escitalopram on quality of life
    - effect of Escitalopram on visceral perception
    - effect of Escitalopram on intestinal permeability
    - effect of Escitalopram on immune status, neurohormones, purinergic signalling and (epi)genetic changes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    IBS will be diagnosed according to the Rome III criteria1 *:
    Recurrent abdominal pain or discomfort at least 3 days per month in the last 3
    months associated with 2 or more of the following:
    • Improvement with defecation.
    • Onset associated with a change in frequency of stool.
    • Onset associated with a change in form (appearance) of stool.
    *Criteria have to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
    *Discomfort means an uncomfortable sensation not described as pain. In pathophysiological research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is an indication for subject’s eligibility.
    2) Subtyping of IBS patients will be performed using the following classification
    according tot the Rome III criteria: IBS with constipation (IBS-C), IBS
    with diarrhea (IBS-D), mixed IBS (IBS-M) or unsubtyped IBS (IBS-U).
    3) Based on the medical history and previous examination, no other causes for the
    abdominal complaints can be defined.
    4) A panic disorder will be diagnosed based on DSM IV criteria.
    5) Age above 18 years and under 70 years.
    6) Given written informed consent.
    E.4Principal exclusion criteria
    1) Inability to stop medication that can influence gastrointestinal motility or perception
    (like loperamide, butylscopolamine, duspatal, metoclopramide, domperidon,
    erytromycine), serotonin metabolism (like carbidopa, food supplementation), or
    epigenitics (like valproic acid), or containing Sint-Janskruid (Hypericum perforatum).
    2) Administration of investigational drugs in the 180 days prior to the study.
    3) Major abdominal surgery interfering with gastrointestinal function (uncomplicated
    appendectomy, cholecystectomy and hysterectomy allowed, and other surgery
    upon judgement of the principle investigator), epilepsy or (hypo)manic episodes.
    4) Pregnancy and lactation.
    5) Excessive alcohol consumption (>20 alcoholic consumption per week) or drug
    abuse.
    6) Co-intervention or other treatment for IBS or anxiety, with the exception of initial
    co-intervention with benzodiazepines (alprazolam) contrasting side effects due to
    SSRIs during the first two weeks of administration or during the first two weeks of
    dose elevation.
    7) Known prolongation of QT-interval or long-QT-syndrome, other cardiac disease,
    or use of medication with known prolongation of QT-interval.
    E.5 End points
    E.5.1Primary end point(s)
    Gastrointestinal Symptom Rating Scale (GSRS) (Self-assessment questionnaire for gastrointestinal symptoms.
    State Trait Anxiety Inventory (STAI) (Self-assessment device, which includes separate measures of state and trait anxiety).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At start, after 3 months, after 6 months.
    E.5.2Secondary end point(s)
    Hospital Anxiety and Depression Scale (HADS).
    Cognitive Scale for Functional Bowel Disorders (CS-FBD).
    Symptom diary.
    Experience Sampling Method (ESM).
    Rectal barostat.
    Sugar permeability test.
    Laboratory measures for immunology, neurohormones, (Epi)genetic factors.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Start of study, after 3 months, after 6 months for the questionnaires and lab. Rectal barostat and Sugar permeability test only at start of study and after 6 months.

    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    not applicable
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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: 80
    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 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 2010-06-17. Yes
    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 state80
    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)
    not different
    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 Decision2010-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-08
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