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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   36614   clinical trials with a EudraCT protocol, of which   6046   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2006-005506-32
    Sponsor's Protocol Code Number:Dulo2006
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-01-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2006-005506-32
    A.3Full title of the trial
    Pain, anxiety and depression in neuropathic and non-neuropathic pain: Effect of monoamine modulation.

    A.4.1Sponsor's protocol code numberDulo2006
    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 SponsorDanish Pain Research Center
    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.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 Yes
    D. name Cymbalta
    D. of the Marketing Authorisation holderEli Lilly
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    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
    Chronic pain: neuropathic pain and fibromyalgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To analyse chronic pain patients with and without neuropathic pain with respect to:
    1) Effect of a balanced serotonergic and noradrenergic reuptake inhibitor (duloxetine) on pain, anxiety and depression measures.
    2) Relation between character and quality of pain, depression and anxiety.
    3) Time course for changes in pain, anxiety and depression following treatment.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients 18-75 years of age.

    2. Patients with neuropathic pain. Diagnoses: peripheral nerve lesion, polyneuropathy in feet, spinal root compression, and post-herpetic neuralgia.

    3. Patients with non-neuropathic pain. Diagnosis: fibromyalgia.

    4. Daily pain present > 6 months.

    5. Mean weekly pain score > 4 on an 11-point Likert scale the last week of the screening period.

    6. Treatment with antidepressants (TCA, SSRI, SNRI, MAOI or others), gabapentin, pregabalin, and carbamazepine must be stopped at least two weeks before treatment phase.

    7. Efficient contraception (women in the fertile age).

    8. Written and verbal informed consent and letter of authority.
    E.4Principal exclusion criteria
    Exclusion criteria:
    Before the beginning of the study
    1. Hypersensitivity to the active substance or to any of the excipients in duloxetine.

    2. Severe renal impairment (creatinine clearance<30 ml/min.)

    3. Liver disease resulting in hepatic impairment.

    4. Comcomitant use of nonselective, irreversible or selective, reversible Monoamine Oxidase Inhibitors (MAOIs) within at least 14 days of discontinuing treatment with MAOI. Based on the half-life of duloxetine, at least 5 days should be allowed after stopping duloxetine before starting an MAOI.

    5. Comcomitant use of fluvoxamine, ciprofloxacin or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine.

    6. Comcomitant use of serotonergic medicinal products: SSRI´s, TCA´s like clomipramine or amitriptyline, john´s wort (hypericum perforatum), SNRI like venlafaxine or triptans, tramadol, pethidine and tryptofan (risk of serotonine syndrome).

    7. Comcomitant use of anticoagulants, medical products known to affect platelet function, diuretic medication, alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines), flecainide, propafenone and metoprolol (risk of interaction).

    8. Serious or unstable medical illness (e.g. apoplexy, Alzheimer’s disease, affected platelet function, dehydration, epilepsy, hypertension, haemodialysis, hyponatremia, fructose intolerance, glucose-galactose malabsorption, haemophilia, increased intraocular pressure, ischemic pain, uncontrolled narrow-angle glaucoma, Raynaud´s phenomenon, sucrose-isomaltase insufficiency, and previous case of anaphylactic shock reaction). Confirmed by medical history and, if possible, compared to medical records.

    9. Current and previous diagnosis of mania, bipolar disorder, psychosis, severe agitation, imminent deliria, suicidal ideation, suicidal behaviour, alcohol or drug dependence (ICD-10). Confirmed by psychiatrical history and, if possible, compared to psychiatrical or medical records.

    10. Prior participation in a duloxetine study.

    11. Pregnancy and lactation.

    After the beginning of the study (discontinuation)

    1. Development of serious adverse effects or hypersensitivity to the active substance or to any of the excipients in duloxetine.

    2. Hamilton Depression score > 18 or Major Depression Inventory > 39.9. (Antidepressant medication will be initiated immediately).

    3. Suicidal ideation and suicidal behaviours (treatment will be initiated immediately).

    4. Pregnancy.

    5. Lack of compliance with regard to intake of study medication and diary records.

    6. Intake of pain and/or antidepressant medication not included in the study.

    7. The patient cannot co-operate during the examination.

    8. The patient wishes to leave the study.

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure will be the reduction in the mean daily pain score as measured by VAS based on measures in the last week of treatment.

    Secondary efficacy measures include Psychological distress (Symptom Checklist-92), Hamilton Depression and Anxiety Rating Scale, Major Depression Inventory, Anxiety Inventory GAD-10, McGill Pain Questionnaire, Patient’s Global Impression of Improvement, assessment of sleep on an 11-point Likert Scale, thermal and pressure pain thresholds, pain areas, capsaicin test, response to cold pressor test and daily intake of concomitant medication during the trial.
    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 No
    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. 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.8.3 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 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
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state86
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 86
    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 Decision2007-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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