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    Summary
    EudraCT Number:2007-004994-25
    Sponsor's Protocol Code Number:CSMS995A2101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-004994-25
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo-controlled, crossover study in women with irritable bowel syndrome to evaluate feasibility and reproducibility of barostat assessments of colorectal sensation during colorectal distention and its pharmacological modulation using octreotide
    A.4.1Sponsor's protocol code numberCSMS995A2101
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.2.5The 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 nameN/A
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOCTREOTIDE ACETATE
    D.3.9.1CAS number 79517-01-4
    D.3.9.2Current sponsor codeSMS995
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Irritable Bowel Syndrom
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess intra-patient reproducibility of barostat assessments of colorectal sensory functions and compliance in irritable bowel syndrome (IBS) patients using repeated baseline barostat measurements
    • To assess which is the most robust colorectal sensory parameter to detect a treatment-related difference in colorectal perception using the ascending method of limits (AML) and random phasic distension (RPD) protocols
    E.2.2Secondary objectives of the trial
    • To evaluate whether a treatment-related difference in colorectal pressure thresholds for first sensation, first desire to defecate, urgency, discomfort and pain perception can be detected using the AML barostat protocol
    • To evaluate whether a treatment-related difference in sensory intensity ratings for gas, urgency, discomfort and pain can be detected using the RPD barostat protocol
    • To assess inter-site differences in the pressure thresholds for first sensation, first desire to defecate, urgency, discomfort and pain perception in the AML and in the sensory intensity ratings for gas, urgency, discomfort and pain in the RPD barostat protocol

    Exploratory objectives:
    • To conduct exploratory studies to identify proteins (TRPV1; PGP9.5), peptides (CGRP; substance P) or genes (TRPV1 mRNA) in mucosal tissue samples and blood that are correlated with visceral hypersensitivity
    • To assess proportions of hyper-/normo-sensitive IBS patients in the study centers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females aged 18-65 years.
    2. A positive diagnosis of IBS according to the Rome III criteria: At least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort associated with 2 or more of the following:
    •Improvement with defecation; and/or
    •Onset associated with a change in frequency of stool; and/or
    •Onset associated with a change in form (appearance) of stool
    - discomfort means an uncomfortable sensation not described as pain.
    3. Subjects must either:
    •have been surgically sterilized (bilateral oophorectomy) or hysterectomized at least 6 months prior to screening. Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions form of the eCRF.
    •be postmenopausal, i.e. must have no regular menstrual bleeding for at least 1 year prior to inclusion. Menopause will be confirmed by a plasma 17ί-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L.
    •female subjects of child bearing potential must be using a double-barrier local contraception, i.e. intra-uterine device plus condom, or diaphragm plus condom, from 1 week before dosing until the end of study. In addition, appropriate precautions will be taken (e.g. Informed Consent, detailed counseling, abstinence during study, and negative pregnancy tests at screening and each baseline, with repetition of pregnancy test at the end of study).
    4. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding women.
    2. Body mass index (BMI) of <18 or >35.
    3. Smoking of greater than 10 cigarettes per day and/or urine cotinine > 200ng/mmol at screening.
    4. History of or evidence for structural diseases/conditions that affect the gastrointestinal system including prior intestinal or colonic surgery (except appendectomy).
    5. Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity; specifically patients with suspected idiopathic chronic constipation must not be included.
    6. Evidence of occult blood at stool analysis, or history of rectal bleeding.
    7. Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception such as laxatives, prokinetics, erythromycin, 5-HT3 antagonists, 5-HT4 agonists, narcotics, pain medication, antispasmodic agents, or serotonin re-uptake inhibitors or tricyclic antidepressants.
    8. Use of intra-vaginal devices (e.g. tampons) during colorectal barostat procedures.
    9. Using or planning to use drugs or agents during the study period that alter blood coagulation like warfarin, heparin, NSAIDs or aspirin.
    10. Diabetes mellitus or poorly controlled thyroid disease (hypo- or hyperthyroidism).
    11. Known gallstones; history of biliary colic pain; history of pancreatitis.
    12. Any clinical evidence (including physical exam, ECG, laboratory tests) of significant intercurrent medical conditions such as cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or of any disease that may interfere with the objectives of the study.
    13. Clinically significant bradycardia with potential to interfere with procedure induced vagal tone (Investigators may be guided by a cut-off heart rate of < 50 bpm).
    14. Psychosis, schizophrenia, mania or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential subject.
    15. Symptoms of a significant clinical illness in the preceding two weeks.
    16. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
    17. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    18. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
    E.5 End points
    E.5.1Primary end point(s)
    - Sensory threshold scales for first sensation, first desire to defecate, urgency, discomfort and pain (one scale for each sensation=4 scales total per barostat procedure)
    - VAS scales at 12, 24, 36 and 48 mmHg for gas, urgency, discomfort and pain (one scale for each sensation at each pressure=16 scales total per barostat procedure)
    - pressure Pr1/2 (mmHg) at half of the maximum observed volume during AML
    - IBS disease activity questionnaire
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    methodological
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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 concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days8
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 46
    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)
    treatment as per prior to study
    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 Decision2008-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-23
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