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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2004-000975-32
    Sponsor's Protocol Code Number:RPCE03L1801
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-09-16
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2004-000975-32
    A.3Full title of the trial
    An exploratory, double blind, randomized, placebo-controlled, prallel group, multicenter study, for the assessment of the efficacy, safety and tolerability of ucb34714 50mg oral capsules in b.i.d. administration at the dose of 200mg/day and 400mg/day, in subjects (at least 18 years old) suffering from post-herpetic neuralgia (PHN).
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberRPCE03L1801
    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 SponsorUCB S.A. - Pharma Sector
    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.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.2.5The 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 nameucb 34714
    D.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Capsule*
    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.3.9.1CAS number 357336-20-0
    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) 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 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.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*
    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
    post-herpetic neuralgia
    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
    to evaluate the efficacy of each dose of ucb 34714 (200 mg/day and 400 mg/day) copared with placebo, in the treatment of post-herpetic neuralgia
    E.2.2Secondary objectives of the trial
    Secondary objective:
    To explore the safety and tolerability of ucb 34714 in the same indication

    Exploratory objective:
    To explore the impact on subject´s self-reported health status
    To collect data on painfree days and on medical resources used during the study
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Written informed consent signed and dated by the subject
    - Male/female subject aged 18 years or older.
    - Pain present for at least 6 months after the healing of the acute herpes zoster skin rash.
    - Pain intensity score assessed on a 11-point numerical pain rating scale with a score of at least 4 at the screening visit (to assess pain intensity during the past 24 hours) and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period as evaluated on a minimum of 4 days.
    - Female chilbearing potential must use medically acceptable method of birth control.
    - Be considered as reliable and capable of adhering to the protocol.
    E.4Principal exclusion criteria
    - Subject getting psychological support to help cope with pain.
    - Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for PHN or who receives TENS.
    - TCAs or non-steroidal anti-inflamatory drug or permitted opioid analgesics that started less than 30 days and /or stabilized prior to screening and/or not expected to be kept at stable dose over the trial period.
    - Patient treated with Carbamazepine.
    - Subject with history of severe advers hematologic reaction to any drug
    - Subject with history of bone marrow depression
    - Any sign suggesting repidly pregressing brain disorder, dementia or brain tumor.
    - Known significant neurological disorder or a condition that can mimic stroke with distal neurological deficit, amyotrophy, radiculopathy, histori of transient ischemic attacks, multiple sclerosis, or any amputations.
    -Subject with immunidepresion
    - Clinically significant ECG abnormalities.
    - Subject with clinically significant deviations from reference range values.
    - Known coexistent source of pinful peripheral neuropathy.
    - Subjects having creatinine clearance< 50mL/min or a history of singificant impaired renal function.
    -Subjects treated in the four weeks prior to screening visit with strong opioids analgesics.
    - Subjects being treated in the two weeks prior to screening visit with: skeletal muscle-relaxants, AEDs, mexiletine, anesthetics, topical analgesics, antiviral agents
    - Subjects treated in the week prior to the screening visit with: any other treatment considered efficacious in the treatment of post-herpetic neuralgia- Aspirin <300 mg/day may be taken for the prophylaxis of myocardial infarction or transient ischemic attacks.
    -Subject treated with over-the-counter and/or homeopathy analgesics.
    - Subject having a past history or is currently abusing alcohol or any other drug according to the DSM-IV criteria.
    -Pregnant, lactating or sexually active woman with childbearing potential who is not using a medically accepted birth control method or who is using an OC containing<30ug ethinylestradiol, in case she is taking hormonal contraception.
    - Known psychiatric condition (inluding suicidal ideation in past three months or history of attempted suicide in the past ten years).
    -Contraindication to any component of the treatments in the trial (ucb 34714 or placebo) or known allergic reaction to or intolerance of pyrrolidine derivates and /or other excipients (principally lactose, cornstarch, cellulose).
    - Subject currently participating or having participated within the last 30 days in another clinical trial.
    - Investigators, co-investigators, theri spouses or children or any trial collaborator may not be included as subjects in the trial.
    - Subject having been blood donator during the previous 3 months or planning to be blood donator during the trial.
    -Presence of any sign suggestign rapidly progressing brain disorder, dementia or brain tumor.
    - Any significant clinical and/or medical contidions (acute or chronic illness such as but not restricted to: severe cardiac dysfunction, bone marrow depression, severe hepatic disease and /or moderate to severe rena impairment) with may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed.
    E.5 End points
    E.5.1Primary end point(s)
    - to evaluate the efficacy of each dose of ucb 34714 (200mg/day and 400mg/day) compared with placebo, in the treatment of Post-herpetic Neuralgia.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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
    - whether the subject completed (final visit performed) or discontinued the trial;
    - whether there is still an unresolved adverse event at the end of the trial- If an AE is still present, Investigators must attempt to follow up the subject until complete resolution/stabilization of the condition with sequelae (the AE is resolved but residual effects are still present), and to report all pertinent information to UCB or dcision not to follow-up with justification.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2004-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-01-05
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