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    Summary
    EudraCT Number:2018-002597-41
    Sponsor's Protocol Code Number:O321
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2018-002597-41
    A.3Full title of the trial
    A multi-centre clinical trial evaluating patients’ ability to independently and safely use the medicinal product indicated in the treatment of erectile dysfunction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-centre clinical trial evaluating patients’ ability to independently and safely use the medicinal product indicated in the treatment of erectile dysfunction
    A.4.1Sponsor's protocol code numberO321
    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 SponsorAdamed Pharma S.A.
    B.1.3.4CountryPoland
    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 supportAdamed Pharma S.A.
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoland Dadej
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressOs. Rzeczypospolitej 6
    B.5.3.2Town/ cityPoznań
    B.5.3.3Post code61-397
    B.5.3.4CountryPoland
    B.5.4Telephone number48501516005
    B.5.6E-mailurologia@vp.pl
    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 Maxon, 50 mg, film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAdamed Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 Film-coated tablet
    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 INNsildenafil citrate
    D.3.9.1CAS number 171599-83-0
    D.3.9.3Other descriptive nameSILDENAFIL CITRATE
    D.3.9.4EV Substance CodeSUB04386MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Erectile dysfunction
    E.1.1.1Medical condition in easily understood language
    Erectile dysfunction, sometimes known as impotence, not allowing to get and maintaining a penis erection sufficient for sexual activity
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052003
    E.1.2Term Erectile dysfunction NOS
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess whether patients using specially designed diagnostic tool can independently make safe decision about whether it is appropriate for them to use or not use sildenafil in dose of 50 mg.
    E.2.2Secondary objectives of the trial
    Assessment of:
    -coherence of a patient’s and investigator’s decision on the possibility of taking sildenafil in certain dose.
    -usefulness of diagnostic tool in the decision making process concerning administration of sildenafil in certain dose.
    -coherence of answers given by patient on questions contained in the diagnostic tool concerning renal function, liver function and blood coagulation, with the findings implied by the results of laboratory blood tests.
    -coherence of answer given by patient with cardiac disorders on question concerning heart function contained in the diagnostic tool, with the findings implied by results of cardiac stress test.
    In regards to patients who receive IMP, the objective is to determine:
    -whether patient used the medication;
    -the patient’s perception on efficacy of used medication (whether its administration allowed achieving and maintaining a penile erection sufficient for sexual performance);
    -whether and what adverse drug reactions occurred.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sex: male.
    2. Patients aged 18 years and older.
    3. Patients able to understand and follow the study procedures.
    4. Patients who report erectile dysfunction during the clinical examination.
    5. Patients who are willing to use pharmacological treatment of erectile dysfunction.
    6. Patients who have had at least one visit to a cardiologist over the past two years and remain under his care due to the diagnosed disorders (additional criterion only for inclusion into the group of patients with cardiac disorders – at least 80 patients in the study).
    E.4Principal exclusion criteria
    1. Lack of reading and writing skills or comprehension in Polish.
    2. Severe physical or mental concomitant disease that might hamper the realization of the trial according to the protocol.
    3. Legal issues (eg. incapacitation) or others that make the patient unable to fully understand the purpose of the study, description of its course and possible consequences.
    4. Unreliability or lack of cooperation.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients who will independently make a safe decision on the possibility of taking sildenafil in dose 50 mg.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 (after the patient uses the diagnostic tool and both patient and Investigator make independent decision on patient’s possibility of taking sildenafil).
    E.5.2Secondary end point(s)
    1. The proportion of patients whose answers given in the diagnostic tool are consistent with the conclusions from the analysis of the results of selected laboratory blood tests parameters.
    2. The proportion of patients with cardiac disorders whose answers on heart function given in the diagnostic tool are consistent with the conclusions of the cardiac stress test results.
    3. The proportion of patients who, coherently with the Investigator’s opinion decide that they can take sildenafil in 25 mg or 50 mg dose, among those who decide about taking it.
    4. The proportion of patients who, coherently with the Investigator’s opinion decide that they cannot take sildenafil in any dose, among those who according to Investigator’s opinion cannot take it.
    5. The proportion of patients whose decision to take sildenafil in 25 mg or 50 mg dose is coherent with the Investigator's opinion.
    6. The proportion of patients who decide that they can take sildenafil in 25 mg or 50 mg dose, among those who according to Investigator’s opinion can take it.
    7. The proportion of patients who will make a decision coherent with the decision indicated by the answers given when using the diagnostic tool.
    8. For a selected group of patients with cardiac disorders (total 20 patients) who will receive the IMP, a descriptive analysis will be carried out on the following matters:
    -whether the patient used the medication;
    -what was the patient's perception on efficacy of used medication (whether its administration allowed achieving and maintaining a penile erection sufficient for sexual performance);
    -whether and what adverse drug reactions have occurred.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End points 3-7 - Visit 1 (after the patient uses the diagnostic tool and both patient and Investigator make independent decision on patient’s possibility of taking sildenafil).
    End Points 3-7 - Visit 1+ obtaining the results of laboratory blood tests and cardiac stress test (if applicable).
    End Point 8 – Visit 2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned18
    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 is defined as the last visit, blood collection for the laboratory test and cardiac stress test (if applicable) of the last patient.
    If the Investigator has direct access to the results of laboratory tests and cardiac stress tests, it is not necessary for patient to deliver these results personally, and the patient's participation in the study will end at the stage of collecting blood sample and performing a cardiag stress test (if applicable).
    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 months3
    E.8.9.1In the Member State concerned days15
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female No
    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 state400
    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 Decision2018-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
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