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    Summary
    EudraCT Number:2004-004334-13
    Sponsor's Protocol Code Number:MSI-1995-203
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-12-06
    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 ConcernedIreland - HPRA
    A.2EudraCT number2004-004334-13
    A.3Full title of the trial
    A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis Subjects
    A.4.1Sponsor's protocol code numberMSI-1995-203
    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 SponsorGenaera Corporation
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Somalgen
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Bago, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationArgentina
    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 nameTalniflumate
    D.3.2Product code MSI-1995
    D.3.4Pharmaceutical form Tablet
    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 INNTalniflumate
    D.3.9.1CAS number 66898-62-2
    D.3.9.2Current sponsor codeMSI-1995
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Cystic Fibrosis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are:

    To evaluate the safety profile of talniflumate compared with that of placebo when administered as two 370 mg tablets, three times daily for 52 weeks.

    To evaluate the efficacy of talniflumate compared with that of placebo when administered as two 370 mg tablets, three times daily for 52 weeks.
    E.2.2Secondary objectives of the trial
    To evaluate at Weeks 2, 4, 8, 20, 32, 46, 48, 50, 52, and Follow-up:
    Change from baseline in (pre- and post-bronchodilator) spirometric measurements of forced vital capacity (FVC) and FEV1.
    Change from baseline in respiratory rate.
    Change from baseline in oxyhemoglobin saturation level.
    Change from baseline in total lung capacity (TLC) and ratio of residual lung volume to total lung capacity (RV/TLC).
    Change from baseline in carbon monoxide diffusing capacity of the lung (DLCO).
    To evaluate at Weeks 8, 32, 52, and Follow-up:
    Acute Respiratory Illness Checklist (ARIC) scores.
    Gastrointestinal tolerability.
    To evaluate the effect of talniflumate on the subject’s health-related quality of life at Weeks 4, 20, 32, 46, 52, and Follow-up.
    To evaluate any dose modification from the baseline due to safety or tolerance.
    To assess the safety of talniflumate.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subject Inclusion Criteria

    Eligible subjects MUST comply with the following criteria:

    1.Be 12 years of age or older, male or female
    2.Have a confirmed diagnosis of CF: sweat chloride ³ 60 meq/L by quantitative pilocarpine iontophoresis test (QPIT) OR homozygosity for DF508 genetic mutation OR heterozygosity for two wellď·“characterized mutations AND one or more clinical findings consistent with CF
    3.Have a forced expiratory volume at 1 second (FEV1) at spirometry ³ 30% of predicted normal for age, gender, and height (Knudson standards)
    4.Have an oxygen saturation (as measured by pulse oximetry) ³ 90% on room air
    5.Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation, as described in Appendix 16.6 Signs and Symptoms of Pulmonary Exacerbation
    6.Be able and willing to follow instructions and complete study procedures
    7.Be able to be present for the required study visits
    8.Provide written informed consent/assent
    9.Be able to reproducibly perform spirometry maneuvers
    10.All females must have a negative serum pregnancy test at the Screening Visit and be practicing a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent) or abstinence, unless surgically sterilized
    11.Agree to avoid pregnancy, and not to nurse a child throughout the study (females of child-bearing potential)
    12.If male, agree to use barrier contraception or abstinence throughout the study (unless surgically sterilized)
    E.4Principal exclusion criteria
    Eligible subjects MUST NOT:

    1.Have abnormal renal or liver function (serum creatinine ³ 2 mg/dL or liver function tests [AST, ALT] ³ 3 ´ upper limit of normal)
    2.Have other clinically significant comorbidities
    3.Have a history of gastrointestinal bleeding, or peptic ulcer disease
    4.Have ECG changes consistent with clinically significant cardiovascular disease
    5.Have discontinued chronic oral or inhaled antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within two month prior to Screening
    6.Have had changes in chronic oral or inhaled antimicrobial agents within six months prior to Screening (stable use for six months or longer is allowed)
    7.Have had change in Pulmozyme (dornase alfa) treatment within six months prior to Screening (stable use for six months or longer is allowed)
    8.Have discontinued Pulmozyme (dornase alfa) within 2 months prior to Screening
    9.Be currently receiving an ACE inhibitor
    10.Be receiving chronic ibuprofen or other NSAID therapy
    11.Have changed their physiotherapy technique or schedule within the week prior to Screening
    12.Be receiving new systemic corticosteroids prior to dosing
    13.Have received new intravenous antibiotics within the four weeks prior to dosing with study medication
    14.Have a history of daily continuous oxygen supplementation or require > 2L/min at night
    15.Have an oxyhemoglobin saturation of less than 90% on room air
    16.Have a history of hypersensitivity to any other NSAID
    17.Have received antitussives, expectorants, or mucolytic agents including dextromethorphan, guaifenesin, menthol, camphor, codeine, iodinated glycerol, N-acetylcysteine within the 2 weeks prior to Screening
    18.Have a condition (e.g., alcoholism, drug abuse, psychiatric condition) that makes it highly unlikely that the course of treatment or follow-up will be completed
    19.Have a chest x-ray at screening (or within the past 6 months of screening) with evidence of an acute segmental or lobar process
    20.Have been exposed to any investigational drug within 30 days prior to screening
    21.Be pregnant, nursing, or expecting or attempting to become pregnant within the next year
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints
    Safety: The cumulative incidence, at Week 52, of adverse events.

    Efficacy: The change from baseline in spirometric (pre-bronchodilator) measurement of forced expiratory volume in one second (FEV1) at Week 52
    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 Information not present in EudraCT
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    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 2004-12-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    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 Decision2005-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
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