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    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-002640-97
    Sponsor's Protocol Code Number:A6121128
    National Competent Authority:Iceland - IMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-10-11
    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 ConcernedIceland - IMCA
    A.2EudraCT number2004-002640-97
    A.3Full title of the trial
    Time to onset of action of tolterodine using force fill cystometry in SPINAL CORD INJURY PATIENTS WITH neurogenic detrusor overactivity.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberA6121128
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorPfizer
    B.1.3.4CountryIceland
    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 Detrusitol
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameDetrol
    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 INNTolterodine tartrate
    D.3.9.3Other descriptive nameDetrol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    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
    Neurogenic detrusor overactivity in patients with spinal cord injury
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare a single oral dose of tolterodine (2 mg) with placebo on the reduction of uninhibited detrusor contractions induced by provocation testing.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety of tolterodine administration in patients with spinal cord injury and pathology.
    2. To explore relationships of the efficacy variables with serum concentrations of tolterodine and/or its active metabolite, DD 01.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female patients aged 18-65 years, with urodynamic evidence of neurogenic detrusor overactivity (phasic or uninhibited detrusor contraction) arising as a consequence of spinal cord injury or pathology.
    2. Evidence of phasic uninhibited detrusor contraction on fast fill cystometry at the beginning of Period 1.
    3. Demonstrable provoked uninhibited detrusor contraction following force fill at the beginning of Period 1.
    4. Subjects capable of understanding and giving written informed consent after full discussion concerning the nature of the research.
    5. Female subjects must have a negative pregnancy test.
    6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    1. Subjects who do not provide written consent to participate in the study
    2. Subjects who have a medical condition that would impair their ability to participate reliably in the study.
    3. Subjects who are pregnant or lactating.
    4. Subjects with a recent history of autonomic dysreflexia (AD) or AD which is associated with urodynamic investigations
    5. Treatment within 7 days (or 5x plasma half-life, if longer) preceding the study, or expected to start treatment during the study with:
    a. anticholinergic drugs
    b. drugs with significant anticholinergic effects such as tricyclic antidepressants
    c. drug treatment for overactive bladder. Estrogen treatment initiated more than 2 months prior to randomization is allowed.
    6. Use of inhibitors of the metabolism of tolterodine:
    a. Potent cytochrome P450 3A4 inhibitors such as macrolide antibiotics (erythromycin and clarithromycin), antifungal agents (ketoconazole and itraconazole), cimetidine, MAOIs, and protease inhibitors. Drugs and/or herbal preparations capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampin, carbamazepine, phenytoin, primidone or St. John’s Wort). These must be discontinued within 30 days (or 5 half-lives of inducing/inhibiting agent, whichever is longer) of enrollment in the study.
    b. Fluoxetine must be discontinued at least 5 weeks before first dose of study medication.
    c. Have consumed grapefruit or grapefruit-containing products within 7 days prior to the first dose of study medication
    7. Subject on a variable dosage of any drug with anticholinergic side effects, or subject expected to start such treatment during the study.
    8. Have a known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to anticholinergic drugs, including tolterodine.
    9. Have contraindications to the use of anticholinergic drugs, e.g., uncontrolled narrow-angle glaucoma, urinary retention, significant urinary outflow obstruction (not including sphincter dyssynergia), gastric retention. Significant urinary outflow obstruction is defined as being a urinary pressure/flow study in the obstructed range of the Abrams/Griffiths nomogram or a maximum urinary flow rate <15 mL/sec.
    10. Subjects who have evidence of alcohol abuse or abuse of controlled substances.
    11. Subject who has received any electrostimulation or bladder retraining within the three months before randomization, or is expected to start such therapy during the study period.
    12. Chronic persistent local pathology that may lead to urinary symptoms e.g. urinary tract infection, marked cystocele or pelvic prolapse, interstitial cystitis, bladder stones, unexplained hematuria (> 1+ on dipstick test unless fully investigated prior to randomization to exclude significant urological disease).
    13. Have a clinically significant ECG abnormality at screening, except those with non-clinically significant sinus tachycardia or sinus bradycardia. Screening 12-lead ECG demonstrating QTC>430 msec (males) and QTc>450 msec (females).
    14. History or evidence of major hematological, renal or hepatic abnormalities (subjects with clinically significant hepatic (Child Pugh C classification) or significant renal impairment serum creatinine 3xULN).
    E.5 End points
    E.5.1Primary end point(s)
    1. Area under the pressure curve of the provoked detrusor contraction
    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 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 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) 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 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 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 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
    End of trial is defined when 8 patients have completed visit 1,2,3, and the follow up telephone visit
    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 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) 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 No
    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 state8
    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 Decision2004-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-28
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
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