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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2012-002748-25
    Sponsor's Protocol Code Number:ICP-112-201
    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:2012-09-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002748-25
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once Daily for 14 Days to Patients with Functional Dyspepsia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once Daily for 14 Days to Patients with Functional Dyspepsia
    A.4.1Sponsor's protocol code numberICP-112-201
    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, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16176217722
    B.5.5Fax number+16174940908
    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 nameIW-9179 Capsules 500ug
    D.3.4Pharmaceutical form Capsule
    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 INNIW-9179
    D.3.9.2Current sponsor codeIW-9179
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    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
    Functional Dyspepsia
    E.1.1.1Medical condition in easily understood language
    upper abdominal pain and burning, bothersome fullness after ordinary sized meals, early fullness that prevents eating a regular meal, upper abdominal bloating, nausea, and belching.
    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 16.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    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 objectives of the study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia, with and without concomitant proton pump inhibitor and/or H2 receptor antagonist (H2RA) administration.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient has signed an ICF before any study-specific procedures are performed;
    2. Patient is a male or non-pregnant, non-breastfeeding female, and is aged 18 years or older at the time of the Screening Visit;
    3. Sexually active female patients of childbearing potential must agree to use one of the following methods of birth control from the date they sign the ICF until the EOS Visit:
    a. Hormonal contraception (i.e., oral contraceptive, contraceptive implant, or injectable hormonal contraceptive)
    b. Intrauterine device
    c. A barrier birth control (e.g., condom or occlusive cap with spermicidal
    foam/gel/film/cream/suppository)
    d. Surgical sterilization (i.e., bilateral oopherectomy, hysterectomy, or tubal ligation)
    e. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy;
    4. Female patients of childbearing potential must complete a serum pregnancy test with negative results at the Screening Visit and a urine pregnancy test with negative results at the Randomization Visit prior to dosing;
    5. Patient meets Rome III criteria for functional dyspepsia at the Screening Visit; in addition,the patient has no evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms:

    Criteria for Functional Dyspepsia:
    Patient reports at least one of the following symptoms for the previous 3 months, with onset at least 6 months prior to the Screening Visit:
    a. Bothersome postprandial fullness, occurring after ordinary-sized meals, more than 1 day per week, and/or
    b. Early satiation that prevents finishing a regular meal, more than one day per week, and/or
    c. Pain or burning localized to the epigastrium at least once per week;
    6. Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient’s gastroduodenal symptoms, such as erosive esophagitis, atrophic gastritis, erosive gastroduodenal lesions, hiatal hernia (if the hiatal hernia is < 2 cm, the patient is eligible for the study), Barrett’s esophagus or dysplasia/neoplasia of the esophagus, stomach, or duodenum.
    An EGD completed prior to the Screening Visit is only acceptable if the patient has not had a significant change in the frequency, severity or type of epigastric symptoms since completing the test. If the patient has had significant changes in epigastric symptoms, the EGD should be repeated during the Screening Period. If the EGD is performed during the
    Screening Period, it must be completed at least 7 days before beginning the Pretreatment Period. It is not required that biopsies be taken as part of the EGD procedure, but biopsy results should be reviewed if they were obtained;
    7. Patient reports an average daily score for postprandial fullness at its worst of ≥ 3.0 during the 14 calendar days before the start of the Treatment Period;
    8. Patients who EITHER:
    a. Have not used a PPI within 4 weeks of the Screening Visit, OR
    b. Have used a PPI and/or H2RA at a stable dose for at least 4 weeks prior to the Screening Visit;
    NOTE: patients who have used an H2RA during the 4 weeks prior to the Screening Visit, but not at a stable dose, must stop using the medication at least one calendar day prior to the Pretreatment Period, as described in Appendix 1.
    9. Patient is compliant with PDA completion, as measured by adequately responding to at least 10 days of PDA questions during the 14 calendar days before the start of the Treatment Period. An adequate response requires the patient to appropriately respond to ≥ 80% of that day’s questions;
    10. Patient is fluent and literate in Dutch, French, or English;
    11. Patient agrees to refrain from making any new, major life-style changes (e.g., starting a new weight loss program or changing their exercise pattern) after the signature of the ICF and through the EOS Visit.
    E.4Principal exclusion criteria
    1. Patient fulfills any of the following criteria related to gastroesophageal reflux disease (GERD):
    a. Reports experiencing heartburn (a burning sensation in the chest) and/or regurgitation (the feeling of fluid or food from the stomach coming up into the mouth or throat) on more than 1 day per week during any of the 4 weeks prior to the Screening Visit, or
    b. Experiences heartburn an average of more than 2 days per week and has an average daily score for heartburn > 1.0 on an 11-point (0-10) NRS during the 14 calendar days before the start of the Treatment Period;
    2. Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma;
    3. Patient has a history of any organic or structural disease that can cause abdominal pain or discomfort, e.g., chronic cholecystitis, biliary colic, symptomatic gallstones, gastric outlet obstruction, pelvic inflammatory disease, endometriosis, ovarian cysts, or chronic
    prostatitis. NOTE: Patients who have had definitive (i.e., curative) treatment of the condition are eligible, provided that the definitive treatment occurred at least 1 year before the Screening Visit, and the patient has had no symptoms associated with the condition for
    at least 1 year;
    4. Patient has a history of significant neurological disease, such as Parkinson’s disease, multiple sclerosis, stroke, or spinal cord injury;
    5. Patient has alarm symptoms suggestive of organic gastrointestinal (GI) disease, such as unexplained anemia, unexplained weight loss, GI bleeding, or dysphagia;
    6. Patient has diabetes mellitus;
    7. Patient fulfills both of the following criteria related to gastroparesis:
    a. Patient has a history of a diagnosis of gastroparesis, or the investigator suspects that the patient’s current abdominal symptoms are caused by gastroparesis and
    b. Patient experiences unexplained vomiting ≥ 2 times during the 4 weeks prior to the Screening Visit;
    8. Patient reports stools described as loose, mushy or watery (Bristol Stool Form Scale [BSFS] score of 6 or 7) >25% of the time during the four weeks prior to the Screening Visit, or during the 14 calendar days before the start of the Treatment Period;
    9. Patient has been diagnosed with, or is suspected of having celiac disease;
    10. Patient has a thyroid-stimulating hormone (TSH) value outside of the normal range at the Screening Visit, or treated hypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the Screening Visit;
    11. Patient has had surgery that meets any of the following criteria:
    a. Surgery of the GI tract (including gastric banding) other than an appendectomy at any time before the Screening Visit
    b. An appendectomy or cholecystectomy during the 3 months before the Screening Visit
    c. Non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit
    d. Other major non-GI surgery during the 30 days before the Screening Visit;
    12. Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable). Note: patients with a history of cancer are allowed provided that the malignancy has been in remission for at least 5 years before the Screening Visit. A complete remission is defined as the disappearance of all signs of cancer in response to
    treatment;
    13. Patient has a history of active alcoholism or drug addiction within 12 months prior to the Screening Visit;
    14. Patient has been hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the Screening Visit;
    15. Patient has ever received IW-9179 or other guanylate cyclase-C (GC-C) agonists, has received an investigational drug during the 3 months before the Screening Visit, or is planning to receive another investigational drug at any time during the study;
    16. Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the IMP (IW-9179 or placebo);
    17. Patient has an acute or chronic condition that, in the investigator’s opinion, would limit the patient’s ability to complete or participate in this clinical study;
    18. Patient has any clinically-significant finding on a physical exam, 12-lead
    electrocardiogram (ECG), or clinical laboratory test after signing the ICF but prior to receiving the first dose of study medication. The investigator will determine if a particular finding is clinically significant and is a contra-indication to taking part in the study;
    For more exclusion criteria see protocol page 39 and 40.
    E.5 End points
    E.5.1Primary end point(s)
    Post-meal Symptom Severity Assessment will be collected via PDA after the meal challenge test at the study center at the Randomization and EOT Visits for the following 7 symptoms: epigastric pain, epigastric burning, bloating, nausea, belching, heartburn, and regurgitation.

    Daily Patient Symptom Severity Assessment will be collected via PDA each day of the Pretreatment, Treatment, and Posttreatment Periods, for the following 11 symptoms: early satiation, postprandial fullness, epigastric pain, epigastric burning, epigastric bloating, nausea, belching, heartburn, regurgitation, nonepigastric pain, and nonepigastric bloating.

    Weekly Symptom Relief Assessment will be collected via PDA on Day 7 and Day 14 of the Treatment Period. Patients will assess their degree of relief of dyspepsia symptoms, early satiation, postprandial fullness, epigastric pain, and epigastric burning during the previous week on a 7-point balanced scale.

    Nepean Dyspepsia Index
    E.5.1.1Timepoint(s) of evaluation of this end point
    see E.5.1
    E.5.2Secondary end point(s)
    Pharmacodynamic Assessments:
    Daily patient assessment of bowel habits will be collected via PDA each day of the Pretreatment, Treatment and Posttreatment Periods. Patients will report the number of BMs, the day of the BM, whether the BM was associated with a sense of complete evacuation, stool consistency on the BSFS, and laxative use.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 trial4
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    After participation has ended treatment is no different from normal treatment for this condition.
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    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-Thu May 02 23:13:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA