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    Summary
    EudraCT Number:2006-003907-38
    Sponsor's Protocol Code Number:DNB-001-CT001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-07
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-003907-38
    A.3Full title of the trial
    A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo Controlled Phase II Study to Investigate the Safety, Efficacy, and Pharmacokinetic Profile of Twice-daily DNB-001 in Previously Untreated Patients with Intraocular Hypertension
    A.4.1Sponsor's protocol code numberDNB-001-CT001
    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 SponsorDanube 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 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 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 nameDNB-001
    D.3.2Product code DNB-001
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 335381-68-5
    D.3.9.2Current sponsor codeDNB-001
    D.3.9.3Other descriptive nameKR-31378
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeBenzopyran derivative; Neuro- and cardioprotective effects in brain, retina and cardiac ischaemia. Shows multiple mechanisms incl. K+-channel opening activity. Intraocular pressure lowering effect.
    D.IMP: 2
    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 nameDNB-001
    D.3.2Product code DNB-001
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 335381-68-5
    D.3.9.2Current sponsor codeDNB-001
    D.3.9.3Other descriptive nameKR 31378
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    D.3.11.13.1Other medicinal product typebenzopyran derivative; neuro- and cardioprotective in brain, retina and cardiac ischaemia; multiple mechanisms of action incl. K+ -channel opening activity. Intraocular pressure lowering effects
    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
    Intraocular hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10021667
    E.1.2Term Increased intraocular pressure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To evaluate the efficacy of 100, 250, 500 and 750 mg of DNB-001 bid p.o. as anti-ocular hypertensive agents compared with placebo administered bid po for 28 days in patients with ocular hypertension.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    To evaluate the safety and pharmacokinetic profile of DNB-001 administered p.o. for 28 days in patients with ocular hypertension.

    PK objectives:
    The primary PK objective is to test for accumulation by intra-individual comparisons of weekly measurements of plasma concentration of DNB-001 at 2 hrs post a.m. dose
    The secondary PK objective is to compare weekly measurements of plasma concentration of DNB-001 at 2 hrs post a.m. dose between treatment groups
    The PK variable is:
    weekly measurement of the plasma concentration of DNB-001 at
    2 hrs post a.m. dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, at least 18 years of age
    2.Patients with ocular hypertension in both eyes
    3.Best corrected ETDRS visual acuity score equivalent to a Snellen score of 20/50 or better in each eye
    4.Written informed consent prior to any study procedure
    5.Ability and willingness to follow study instructions and likely to complete all study visits
    6. Screening (day -30 ~ -1) negative urine pregnancy test for all female patients prior to entry into the study, unless they are postmenopausal for at least one year and/or hysterectomised and/or have a documented medical history of clinical inability to become pregnant.
    7.Screening (day -30 ~ -1) IOP higher or equal to 21 mm Hg and ≤ 29 mm Hg in each eye
    8.Body mass index (BMI) between 18.5 and 30 kg/m²
    9.Patients who are healthy as determined by pre-study medical history, physical examination and the absence of protocol-specified ECG abnormalities on the Visit 1 ECG
    10.Patients who had clinical laboratory tests within the reference ranges or clinically acceptable to the investigator
    11.Subjects who are negative for hepatitis B surface antigen (HBsAg) and hepatitis C antibody
    E.4Principal exclusion criteria
    1.Prior diagnosis of glaucoma of any type
    2.Subjects with uncontrolled systemic disease of any type. Patients receiving insulin for diabetes mellitus will not be admitted to the study
    3.All female patients of childbearing potential. Participating females need to be postmenopausal for at least one year and/or hysterectomised and/or need to have a documented medical history of clinical inability to become pregnant. Male patients have to use barrier contraception (condoms plus spermicidal jelly) during the study or have to be surgically sterile
    4.Use of any ocular anti-hypertensive medication, topical or systemic in the past 3 months from screening date
    5.Known allergy or sensitivity to the study medications
    6.Anticipated alteration in chronic therapy with or introduction of agents known to have a substantial effect on IOP (e.g. beta-adrenergic blocking agents)
    7. Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
    8.Use of oral, injectable or topical ophthalmic steroid within the past 21 days from screening date
    9. History of ocular allergy
    10. Any active ocular disease (e.g. uveitis, ocular infection, severe dry eye). Patients may have cataracts, age-related macular degeneration or background diabetic retinopathy if, in the opinion of the Investigator, it would not interfere with the conduct of the study
    11. Required use of ocular medication (including artificial tears) during the study
    12. Significant visual field loss or progressive field loss during the past year.
    13. Significant optic nerve abnormality in the opinion of the Investigator as determined by ophthalmoscopy
    14. Presence of optic nerve head haemorrhage
    15. Gonioscopy consistent with potential angle closure glaucoma
    16. Intraocular surgery within the past 6 months from screening date
    17. Past history of any laser or filtering surgery for glaucoma
    18. Refractive surgery of any type within the past 3 months from screening date
    19. Inability to visualise the patient’s optic nerve
    20. Any abnormal lab values at Screening related to liver function (e.g. aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP] or bilirubin)
    21. Anticipated change in dosage of or introduction of new medications for chronic cardiac, pulmonary or hypertensive conditions
    22. Anticipated change in over-the-counter medications, vitamins or herbal products during the course of the study
    23. Use of acetaminophen (paracetamol) during the study
    24. Current enrolment in an investigational drug or device study or participation in such a study within 30 days of screening
    25. History of drug or alcohol abuse within the past one year
    26. Patient has any condition or situation that, in the Investigator’s opinion, might confound the results of the study, may put the patient at significant risk or might interfere with the patient’s ability to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is defined as the percentage change of IOP from baseline (at 10 a.m. [+/- 1 hr] prior to the study medication) up to Visit 6 (Day 28) at Hour 2 ([+/- 1 hr) post a.m. dosing under treatment with DNB-001 or placebo.
    The reduction of IOP is calculated on the basis of the arithmetic mean of up to six IOP measurements (3 IOP measurements per eye)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Standard treatment or care will be given to the patients.
    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 Decision2007-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-24
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