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    Summary
    EudraCT Number:2013-002226-23
    Sponsor's Protocol Code Number:2013-002226-23
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-12
    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 ConcernedNorway - NOMA
    A.2EudraCT number2013-002226-23
    A.3Full title of the trial
    Efficacy of Pain Treatment on Depression in Patients with Dementia. A Randomized Clinical Trial of Efficacy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Pain Treatment on Depression in Patients with Dementia
    A.3.2Name or abbreviated title of the trial where available
    DEP.PAIN.DEM
    A.4.1Sponsor's protocol code number2013-002226-23
    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 SponsorUniversity of Bergen, Department of Global Public Health and Primary Care
    B.1.3.4CountryNorway
    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 supportNorwegian Research Council
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorwegin Research Council
    B.5.2Functional name of contact pointFri prosjectstøtte for medisin
    B.5.3 Address:
    B.5.3.1Street AddressStensberggt 26
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0131
    B.5.3.4CountryNorway
    B.5.4Telephone number+4722037000
    B.5.5Fax number+4722037001
    B.5.6E-mailpost@forskningsradet.no
    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 Paracet <Weifa>
    D.2.1.1.2Name of the Marketing Authorisation holderWeifa AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameParacet <Weifa>
    D.3.2Product code N02B E01
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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 Norspan patch
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameNorspan patch / Buprenorphine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    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
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depression
    Pain
    Dementia
    E.1.1.1Medical condition in easily understood language
    Depression
    Pain
    Dementia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    Main-goal
    Explore whether pain management can improve depression in patients with dementia
    E.2.2Secondary objectives of the trial
    Sub-goals
    a)Explore the relationship between pain and depression in dementia.
    b)Explore the relationship of pain measurements (pain diagnoses, -intensity, -location) with frequency and severity of depression in patients at different levels of dementia
    c)Explore the relationship between different grades of pain and grades of depression, anxiety, sadness, appetite, or pessimism, i.e. which depressive symptoms are associated with pain
    d)Explore the relationship between different grades of pain treatment and severity of depression in patients with dementia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    We will conduct a multicentre, parallel-group, 13-week double-blind, placebo-controlled RCT of participants from 38 nursing homes in Bergen, Stavanger, Sogn og Fjordane, Oslo and Bærum.

    Participants
    Participants (N=266) are eligible if they are 60 years and older and have probable or possible dementia, in accordance to the National Institute of Neurological and Communicative Diseases and Stroke (NINCDS) – Alzheimer`s Disease and Related Disorders Association (ADRDA) and coexisting depression (≥ 4 weeks` duration) that was assessed as potentially needing antidepressants or despite ongoing treatment with antidepressant. A research worker will assess depression severity with the CSDD,9 with eligible participants scoring ≥ 8. Participants are ineligible if they are clinical critical (e.g. suicide risk), contraindicated to study drugs of pain treatment, in another trial, or had no carer. Study design allows ongoing treatment with antidepressant if remained stable for 4 weeks prior to study inclusion.
    E.4Principal exclusion criteria
    Exclusion criteria will be advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder, severe aggression (agitation score ≥ 8 on the NPI-NH, 24 with aggression as the predominant symptom).
    E.5 End points
    E.5.1Primary end point(s)
    Primary and secondary outcomes will be collected at baseline, week 6 and 13.
    Primary outcome measure is the CSDD, validated among persons with and without dementia. Each of the 19 items is rated from 0 (no symptom) to 2 (severe). CSDD allows rating: “symptom impossible to evaluate”. Depression is defined as a score ≥ 8; mild depression as a score 8-11 and moderate–severe depression >12. Inter-rater reliability (0.73–1.00) and validity were examined and suggested to be satisfactory. Correlation coefficients of CSDD sum scores were high.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, week 6 and 13
    E.5.2Secondary end point(s)
    Secondary outcome measures
    o Neuropsychiatric Inventory-Nursing Home version, NPI-NH, a caregiver based interview, assessing delusion, hallucination, agitation, depression, anxiety, disinhibition, apathy, irritability, aberrant motor activity, sleep, appetite. Total and subscale scores are provided with frequency, severity, and caregiver’s distress (total score 1-144).
    o In a series of studies, our research group developed and tested a pain measurement, Mobilization– Observation – Behavior – Intensity – Dementia-2 Pain Scale (MOBID-2), a nurse-administered pain tool for dementia, which assesses pain intensity related to internal organs, head and skin based on pain behaviours. Good kappa agreements are shown for pain behaviour and -drawings. Inter-rater and test-retest reliability, and Cronbach’s α for pain intensity is high.
    o Numerical Rating Scale (NRS) is a 0-10 horizontal scale (0=no pain, 10=as bad as possible). If possible, patients will be asked whether they are in pain at that moment (yes/no) and then asked to complete to score any pain experienced at that time by NRS.
    o Activities of Daily Living (ADL) assess physical function. Rating includes activities like feeding, moving, personal toilet, and dressing higher values indicating higher levels of activities of daily functioning and independency. The scale includes 10 items (0-20 score).
    o Mini-Mental State Examination (MMSE), enables cut-off differentiation for levels of dementia severity (0-11=severe, 12-17=moderate, 18-23=mild, 24-30=no impairment).
    o HQoL will be assessed by DEMQoL (28 items), a new tool appropriate for use at all stages of dementia severity, available in self- and proxy-report version.
    o UKU safety scale to investigate side effects in treatment with antidepressant. Safety and tolerability assessments will record all adverse events (AE) and serious adverse events (SAE) and vital signs at each assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, week 6 and 13
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 Yes
    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
    Last visit/investigation at week 13 using: Depression - Cornell Scale; Neuropsychiatric Inventory - Nursing Home version (NPI-NH); Pain - MOBID-2 Pain Scale; Quality of Life - QUALID and QoL-AD; Economics-UKU; Mental Staging - MMSE; Activities of Daily Living ADL, and adverse events.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 266
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In patients with dementia, verbal and written informed and presumed consent will be obtained in direct conversation with the patient and his legal guardian, usually a family member or advocate, after explaining the aims of the study/protocol.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state266
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 266
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Karolinska Institute
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Kings College, London
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation University of Bergen
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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