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    Summary
    EudraCT Number:2007-002087-10
    Sponsor's Protocol Code Number:1062.7
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-002087-10
    A.3Full title of the trial
    A randomised, double -blind, placebo-controlled, parallel group study to assess the efficacy and safety of 4 weeks treatment with sodium picosulphate [Dulcolax®, Laxoberal®] drops 10 mg administered orally, once daily, in patients with functional constipation.
    A.4.1Sponsor's protocol code number1062.7
    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 SponsorBoehringer Ingelheim Pharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 Dulcolax NP Tropfen
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharma GmbH und Co KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDulcolax
    D.3.4Pharmaceutical form Oral drops, solution
    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 INNSodiumpicosulphate-Monohydrate
    D.3.9.1CAS number 10040-45-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 placeboOral drops, solution
    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
    To compare the efficacy and safety of 4 weeks treatment with sodium picosulphate [Dulcolax®, Laxoberal®] drops to placebo in patients with functional constipation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to compare the efficacy and safety of 4 weeks treatment with sodium picosulphate (Laxoberal®, Dulcolax®) drops 10 mg to placebo in patients with functional constipation.
    E.2.2Secondary objectives of the trial
    In addition, the effect of treatment on quality of life and general health status will also be
    evaluated
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    3.3.1 Inclusion criteria
    1. Male and female patients, aged 18 and above
    2. Suffering from functional constipation, according to their medical history, as defined
    by the Rome III diagnostic criteria (Appendix 10.3), i.e.:
    Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to
    diagnosis.
    a. Must include 2 or more of the following:
    o straining during at least 25% of the defecations
    o lumpy or hard stools in at least 25% of the defecations
    o sensation of incomplete evacuation for at least 25% of the defecations
    o sensation of anorectal obstruction/blockade for at least 25% of the
    defecations
    o manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital
    evacuation, support of the pelvic floor)
    o fewer than 3 defecations per week
    b. Loose stools are rarely present without the use of laxatives
    c. There are insufficient criteria for irritable bowel syndrome (IBS) (i.e. recurrent
    abdominal pain or discomfort is not the predominant symptom associated with
    defecation or a change in bowel habit, and with features of disordered defecation)
    3. Able and willing to complete a daily e-diary
    4. Able and willing to use the trial rescue medication (i.e. 10 mg bisacodyl [Dulcolax®]
    suppositories)
    5. Signed and dated written informed consent prior to enrolment into the study in
    accordance with GCP and local legislation
    At Visit 2 (i.e. at the end of the baseline period), patients must comply with the following
    additional inclusion criteria to be eligible for entry into the treatment phase:
    6. Functional constipation is confirmed by e-diary data at the end of the baseline period,
    according to the following definition:
    a. An average of less than 3 CSBMs per week, together with at least one of the
    following symptoms occurring at least 25% of the time:
    o straining
    o incomplete evacuation
    o lumpy or hard stools (i.e. type 1 or type 2 stools according to the 7-point
    Bristol Stool Form Scale, see Appendix 10.4)
    7. Compliant with the use of the e-diary throughout the baseline period (compliance is
    defined as completing 80% of the e-diary evening reports, see Section 5.1.1.1)
    8. Compliant with the use of the trial rescue medication (i.e. 10 mg bisacodyl
    [Dulcolax®] suppositories) throughout the baseline period. Compliance is defined as
    follows:
    o rescue medication may be used if there has not been a bowel movement for more
    than 72 hours
    o rescue medication may not be used on either day -1 or on the day of randomisation
    (day 1)
    E.4Principal exclusion criteria
    3.3.2 Exclusion criteria
    At the screening visit (Visit 1), patients must not comply with any of the following exclusion
    criteria to be eligible for entry into the baseline period:
    1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of
    laxatives
    2. Patients whose constipation is caused by primary organic disease of the colon or
    pelvic floor
    3. Patients with metabolic disorders, neurological disorders, severe or psychiatric
    disorders, or any other significant disease or intercurrent illness (e.g.
    abdominal/gastrointestinal surgery) that, in the Investigators’ opinion, would interferewith participation in the trial
    4. Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the
    Investigators’ opinion, would interfere with participation in the trial
    5. Patients with a known hypersensitivity to sodium picosulphate, bisacodyl or any other
    ingredient in the study medication (sodium picosulphate [Dulcolax®, Laxoberal®] and
    matching placebo drops, bisacodyl [Dulcolax®] suppositories)
    6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such
    as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration
    7. Patients with anal fissures or ulcerative proctitis with mucosal damage
    8. Patients with known clinically significant abnormal electrolyte values
    9. Patients whose concomitant therapy includes an opioid medication (e.g. morphine,
    codeine)
    10. Constipation which, in the Investigators’ opinion, is caused by medication (e.g.
    anticholinergics)
    11. Patients who are not willing to discont inue the use of prohibited concomitant therapy
    (see Section 4.2.2)
    12. Pre-menopausal women (last menstruation £ 1 year prior to signing informed consent)
    who:
    i. are nursing (breast-feeding) or who are pregnant OR
    ii. who are of child-bearing potential and are not practicing an acceptable method of
    birth control, or do not plan to continue using this method throughout the study.
    Acceptable methods of birth control include:
    1. transdermal patch
    2. intra-uterine devices/systems (IUDs/IUSs)
    3. oral, implantable or injectable contraceptives
    4. sexual abstinence
    5. sterilisation or a vasectomised partner
    13. Participation in another trial with an investigational product with 1 month of
    enrolment into this study
    14. Drug or alcohol abuse
    15. Concomitant use of antibiotics
    At Visit 2 (i.e. at the end of the baseline period), patients must not comply with any of the
    following additional exclusion criteria if they are to remain eligible for entry into the
    treatment phase:
    16. Clinically significant abnormal electrolyte values identified following the central
    laboratory analysis at the screening visit (Visit 1)
    17. Loose or watery stools (i.e. type 6 or type 7 according to the 7-point Bristol Stool
    Form Scale, see Appendix 10.4) for a total of 3 days or more during the baseline
    period
    18. Persons committed to an institution following an order issued by either the judicial or administrative authorities (cf. section 40, para 1, clause 3 No. 4 German Medicines Act.)
    E.5 End points
    E.5.1Primary end point(s)
    2.2 PRIMARY ENDPOINT(S)
    The primary endpoint in this trial is the mean number of complete spontaneous bowel
    movements (CSBMs) per week, during the 4 week treatment phase of the trial.
    A spontaneous bowel movement (SBM) is defined as a non rescue medication induced stool,
    a CSBM is defined as a SBM with a sensation of complete evacuation:
    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 Yes
    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.8.3 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 concerned45
    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 Information not present in EudraCT
    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
    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 months1
    E.8.9.1In the Member State concerned days
    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 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 state360
    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)
    At the end of the trial, patients should be informed that they can now return to using their original laxative(s) or other medication for their constipation should they wish to do so.
    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 Decision2007-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-07
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