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    Summary
    EudraCT Number:2006-000475-16
    Sponsor's Protocol Code Number:2006-001-Oxy-OAB-Skin-Oxy
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-05-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-000475-16
    A.3Full title of the trial
    Prospective, randomized, open, crossover, patient preference study comparing oral immediate release and transdermal oxybutynin in overactive bladder patients
    A.4.1Sponsor's protocol code number2006-001-Oxy-OAB-Skin-Oxy
    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 SponsorJohannes Gutenberg-Universität Mainz, Urologische Klinik (ausführende Stelle), Prof. Dr. med. Thürof
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 RoleComparator
    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 Oxybutynin-ratiopharm 5 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH, Graf-Arco-Str. 3, D-89013 Ulm
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameOxybutynin-ratiopharm 5mg
    D.3.2Product code 39432.00.00
    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 INNOxybutyninhydrochlorid
    D.3.9.1CAS number 1508-65-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 Yes
    D.2.1.1.1Trade name Kentera transdermal patch
    D.2.1.1.2Name of the Marketing Authorisation holderNicobrand Limited, 189 Castleroe Road, Coleraine, Nothern Ireland, BT513RP
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameKentera transdermal patch
    D.3.2Product code EU/1/03/270/001
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxybutynin
    D.3.9.1CAS number 5633-20-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,1625
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    •Male or female (18 – 80 years) suffering from OAB.
    •Symptoms of OAB as defined by:
    Urgency frequency ≥7 /week,•Urinary urgency incontinence (≥ 7 UIE/week),•Urodynamically proven detrusor instability
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    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 trial will be the treatment preference of subjects who will be asked at the end of the 2nd treatment period after both treatment phases. The preference will be checked for its plausibility in an end-of-period satisfaction rating (total of scores on 4 items of final list of questions: 6=very satisfied, 0= very dissatisfied). Treatment satisfaction will be assessed at the end of each period of the cross over. The total score on the satisfaction questionnaire of the two treatment periods will be compared to express preference.
    E.2.2Secondary objectives of the trial
     Assessment of cognitive abilities during treatment with orally administered oxybutynin verus transdermal applicated Oxybutynin
     Quality of life
     Reports of AE/SAE.
     Frequency of micturition
     Frequency of urinary incontinence episodes
     Severity of urinary incontinence episodes
     Urgency frequency
     Treatment satisfaction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male or female (18 – 80 years) suffering from OAB.
    •Symptoms of OAB as defined by:
    •Urgency frequency ≥7 /week
    •Urinary urgency incontinence (≥ 7 UIE/week)
    •Urodynamically proven detrusor instability
    •Women must be surgically sterile or
    •Women must be postmenopausal (postmenopausal means a period after menopause, thus the time of the last menstruation, which follows retrospectively two years long no further ovariell controlled uterine bleeding) or
    •Women mus be older than 55 years and received in the last 5 months no hormone substitution therapy or
    •Women must agree to use effective contraception during treatment phases (i.e. contraceptions with a failure ratio of < 1%/year are implants, injection preparations, combined oral contraceptiva, intrauterine device (e.g. hormone spiral) or vasectomy of the partner)
    •Negative urine pregnancy test for women capable of child-bearing within 24 hours before income of the first dose medication at V1.
    •Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
    •Ability of subject to understand character and individual consequences of clinical trial.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following criteria as according to their history will not be included in the trial:
    •Pregnancy and lactation.
    •History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
    •Subjects with uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg and diastolic blood pressure > 100 mmHg)
    •Subjects with clinically relevant arrhythmic changes in ECG (e.g. AV-block grade II or III, QT-prolongations, Long QT syndrome)
    •Subjects with factors of risk for Torsade de Pointes
    •Subjects with cardiac insufficiency (NYHA II – NYHA IV)
    •Subjects with hypokalaemia
    •Subjects with drugs which have prolongation potential
    •Subjects with coronary heart disease (CHD)
    •Subjects with hyperthyroidism
    •Subjects being treated with CYP3A4-inhibitors like azole antifungals (e.g. ketoconasole) or macrolid antibiotics (e.g. erythromycin).
    •Subjects with uncontrolled narrow-angle glaucoma.
    •Subjects with myasthenia gravis.
    •Subjects with significant urinary obstruction as measured during cystometry (e.g. prostatic hyperplasia, stricture of urethra).
    •Subjects with significant obstructions in the area of the residual urinary tract and the gastrointestinal tract.
    •Subjects with intestinal atony or bowel obstruction.
    •Subjects with severe gastro-intestinal condition (e.g. severe ulcerative colitis or toxic megacolon).
    •Subjects with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
    •Subjects with urinary frequency or nocturia due to cardiac or renal insufficiency and without urgency.
    •Subjects with severe liver insufficiency (e.g. cirrhosis, CHILD-Pugh B and C ).
    •Subjects with severe kidney insufficiency (Creatinin-Clearance < 30 ml/min).
    •Subjects with urinary retention.
    •Subjects with hiatus hernia and reflux oesophagitis
    •Subjects with acute prostatitis.
    •Subjects with tachyarrhythmia (pulse > 100/min).
    •Subjects with Parkinson`s disease or Alzheimer`s disease or other cerebral diseases.
    •Subjects being treated with other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones), quinidine, tricyclic antidepressants, atropine and related compounds.
    •Subjects with cognitive impairment, not able to understand content and aim of the trial.
    •Refractory to antimuscarine treatment: Subjects having experienced no benefit from previous treatment with oral or transdermal oxybutynin.
    •Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
    •Participation in other clinical trials and observation period of competing trials, respectively.
    •Subjects who have previously been enrolled in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is treatment preference of the subjects who will be asked at the end of the 2nd treatment period. The preference will be checked for its plausibility in an end-of-period satisfaction rating. Treatment satisfaction will be assessed at the end of each period of the cross over. The total score on the satisfaction questionnaire of the two treatment periods will be compared to express preference.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 months
    E.8.9.1In the Member State concerned days
    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 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 2007-05-10. Yes
    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 state80
    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 Decision2007-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-02-17
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