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    Summary
    EudraCT Number:2016-000818-29
    Sponsor's Protocol Code Number:MCP-103-403
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000818-29
    A.3Full title of the trial
    A Phase 4, Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study of the Effect of Linaclotide on Abdominal Girth in Participants with Irritable Bowel Syndrome with Constipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to establish whether Linaclotide is effective in reducing abominal distension in men and women with constipation predominant IBS
    A.4.1Sponsor's protocol code numberMCP-103-403
    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 SponsorIronwood Pharmaceuticals, 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 supportIronwood Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIronwood Pharmaceuticals Inc.
    B.5.2Functional name of contact pointCorporate Communications
    B.5.3 Address:
    B.5.3.1Street Address301 Binney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617621 7722
    B.5.5Fax number+1617494 0908
    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 LINZESS
    D.2.1.1.2Name of the Marketing Authorisation holderForest Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Capsule, hard
    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 INNLinaclotide
    D.3.9.1CAS number 851199-59-2
    D.3.9.3Other descriptive nameLINACLOTIDE
    D.3.9.4EV Substance CodeSUB32529
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number290
    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 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
    Irritable Bowel Syndrome with Constipation
    E.1.1.1Medical condition in easily understood language
    Irritable Bowel Syndrome with Constipation
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066868
    E.1.2Term Constipation predominant irritable bowel syndrome
    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 determine the effect of linaclotide on abdominal girth in irritable bowel syndrome with constipation (IBS-C) participants with baseline symptoms of abdominal bloating and an increased abdominal girth.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
    2. Participant is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older (no upper age limit).
    3. Female participants of childbearing potential must complete a urine pregnancy test with negative results at the Screening Visit (Visit 1) and again at the Randomisation Visit (Visit 4) prior to dosing.
    4. Female participants who are pre-menopausal should be enrolled between days 7 and 21 of their menstrual cycle.
    5. Sexually active female participants of childbearing potential must agree to use one of the following methods of contraception from the date that they sign the ICF until the end of study:
    a. Hormonal contraception (i.e., oral contraceptive, contraceptive implant, or injectable hormonal contraceptive);
    b. Intra-uterine device (IUD);
    c. A barrier birth control (such as condoms or occlusive cap with spermicidal foam/gel/film/cream/suppository);
    d. Surgical sterilisation (i.e., bilateral oophorectomy, hysterectomy, or tubal ligation);
    e. Abstinence, when in the opinion of the Investigator, the participant’s occupation or lifestyle gives sufficient evidence that abstinence will be maintained throughout the study and for 1 month thereafter.
    6. Participant meets Rome III criteria for IBS-C, as well as abdominal pain score (average of ≥ 3 on 0-10 point numerical rating scale [NRS]), abdominal bloating score (average of ≥ 5 on 0-10 point NRS), and abdominal girth measurement (AIP increase of > 4 cm) criteria during the Pretreatment Period.
    7. Participant agrees to refrain from strenuous physical activity for 24 hours prior to each study visit.
    8. Participant agrees to refrain from initiating any lifestyle or dietary changes.
    9. Participant agrees to refrain from taking any probiotics from 14 days prior to enrolment in the study throughout the Treatment Period.
    10. Participant is able to communicate well with the Investigator and to comply with the requirements for the entire study.
    11. Participant has a body mass index (BMI) between 18.5 and 34.9 kg/m2 (bounds included) at the Screening Visit.
    E.4Principal exclusion criteria
    1. Participant reports loose (mushy) or watery stools (BSFS score of 6 or 7) in the absence of any laxative, suppository, enema, or prohibited medicine (as described in Appendix 1) for > 25% of BMs during the 12 weeks before the Screening Visit.
    2. Participant has ever had a diagnosis of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer, or inflammatory bowel disease.
    3. Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding, iron-deficiency anaemia or any unexplained anaemia, or weight loss) or systemic signs of infection or colitis.
    4. Participant currently has active peptic ulcer disease (i.e., disease that is not adequately treated or stable with therapy).
    5. Participant has a history of any chronic GI condition (e.g., diverticulitis) that can be associated with abdominal pain or discomfort.
    6. Participant has CNS disease or any organic condition associated with constipation.
    7. Participant has had surgery that meets any of the following criteria:
    a. Has undergone any surgery within 6 months prior to the Screening Visit;
    b. Has had previous abdominal surgery except appendectomy, cholecystectomy, or hysterectomy.
    8. Participant has diabetes.
    9. Participant reports using a Prohibited Medicine (excluding laxatives, suppositories, and enemas) during the Pretreatment Period or is not willing or able to abide by the restrictions regarding use of Prohibited Medicines defined in Appendix 1. (Note: the use of fibre, bulk laxatives, or stool softeners [such as docusate] is acceptable provided that the participant has been on a stable dose during the 30 days before the Screening Visit and plans to continue on
    a stable dose throughout the study.)
    10. Participant has taken commercially available linaclotide during the 30 days prior to the Screening Visit.
    11. Participant is drinking alcohol above the recommended safe alcohol limit (< 21 units/week) or abusing drugs. In addition, participants will be asked to refrain from drinking alcohol for 24 hours before plethysmography recordings until belt removal.
    12. Participant has lactose intolerance.
    13. Participant has an acute or chronic condition that, in the Investigator’s opinion, would limit the participant’s ability to complete or participate in this clinical study.
    14. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
    15. Participant has a known or suspected mechanical gastrointestinal obstruction.
    16. Participant has a history of hypersensitivity to linaclotide or to any of the excipients contained in the study drug (active or placebo).
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from randomisation (Visit 4) to the end of the study (Visit 8) in abdominal girth (as measured by AUC) determined by 24-hour AIP between the linaclotide and placebo groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data on abdominal girth will be downloaded and analysed from the data logger by a blinded member of the research team when participants return with the belt at the Randomisation, Day 15, and End of Treatment Visits.

    Comparisons of the mean change in abdominal girth over 24 hours (as measured by AUC) will be made between the baseline and mid-study, and baseline and end-of-treatment assessments.
    E.5.2Secondary end point(s)
    The secondary efficacy assessments are the diary questions that determine the following:
    • Daily participant assessment of abdominal pain, discomfort, bloating, and distension;
    • Whether a BM is an SBM;
    • Whether an SBM is a CSBM;
    • Stool consistency (Bristol Stool Form Scale [BSFS]) with each BM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    To determine these secondary outcome measures, participants will be asked to complete paper daily diaries in the evening (or approximately the same time each day).
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    The end of the trial will be the date the last subject completes the Follow-up Telephone Call on Day 36.
    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 months10
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days30
    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: 40
    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 state40
    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)
    None
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-30
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