Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-003913-18
    Sponsor's Protocol Code Number:CSAB378A2201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-04-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-003913-18
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the safety and efficacy of SAB378 (15 mg t.i.d.) administered orally for 4 weeks to patients with postherpetic neuralgia
    A.4.1Sponsor's protocol code numberCSAB378A2201
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.2.5The 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 nameN/A
    D.3.2Product code SAB378
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot established
    D.3.9.1CAS number 432047-72-8
    D.3.9.2Current sponsor codeSAB378
    D.3.9.3Other descriptive name-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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
    Postherpetic neuralgia (PHN)
    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
    Demonstrate the efficacy of SAB378 in patients with PHN by testing the hypothesis that SAB378 15mag t.i.d. is superior to placebo on reduction in pain intensity as measured by an 11-point numerical rating scale (NRS) during the last week of double-blind treatment compared to baseline.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of SAB378 in patients with PHN by comparing the frequency of AEs and of treatment-emergent laboratory, ECG and vital sign abnormalities on SAB378 15mg t.i.d. with those on placebo.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male and female outpatients 50 year old or older.
    2. History of PHN for 3 months after healing of a herpes zoster skin rash.
    3. Pain due to PHN at least 5 on 11-point NRS in 24 hours preceding Visit 1
    4. Average pain due to PHN must be at least 5 on 11-point NRS during pre-randomization phase.
    5. Pain intensity due to PHN at least 50 mm on 100 mm visual analogue scale (VAS) in the last 7 days prior to randomization.
    6. Patients must have completed NRS ratings at least 4 days in diary in last 7 days prior to randomization.
    7. Post-menopausal women defined as 24 months of natural (spontaneous) amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophroectomy with or without hysterectomy. Premenopausal women must have been surgically sterilised at least six months prior to screening. Surgical sterilisation procedures must be supported with clinical documentation made available to sponsor and noted Relevant Medical History/ Current Medical Conditions sections of the electronic Case eport Forms (eCRFs).
    8. Male patients must be either surgically incapable of bearing children or practicing at minimum, a combination of double barrier method such as male or female condom with spermicical gel, diaphragm, sponge or cervical cap. A male patient and his partner must comply with an acceptable contraception method. Abstinence will be considered as an acceptable method of contraception. In addition, if female partners of male patients meet the criteria of the female patients entering the trial, male patients will be considered to enter the study, without practising contraception.
    9. Patients must not receive conconimitant medication for PHN, or must be maintained on a stable dose of one allowable concomitant PHN medication (e.g. pregabalin, gabapentin, tricyclic antidepressants) for at least 1 month prior to randomization.
    10. Patients must be willing to give informed consent according to the legal requirements for their respective countries.
    E.4Principal exclusion criteria
    1. Patients who have other pain that could confound the assessment neuropathic pin to PHN.
    2. Patients with skin conditions in are area affected by neuralgia that could alter sensation.
    3. Patients with neurolytic or neurosurgical treatment for PHN.
    4. Patients, who are in an immunocomprised state, e.g. have known or suspected chronic infectous disease including HIV or hepatitis B or C.
    5. Patients with clinically significant psychiatric diagnosis, in particular depression, that would impair their reliable participation in this trial, or patients with significant psychosocial problems that can be related to pain complaints.
    6. Women with child bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterlised by vasectomy or other means.
    7. Patients with Body Mass Index >35Kg/m2.
    8. Patients with low blood pressure (systolic blood pressure <90 mm Hg and/or diastolic blood pressure <60 mm Hg), or orthostatic hypotension (defined as supine-standing systolic BP drop >20 mm Hg or a suprine-standing diastolic BP drop >10 mm Hg) at baseline.
    9. Patients with history of cerebrovascular disease (confirmed treatment ischaemic attacks, reversible ischemic neurolgic deficits, and/ or stroke).
    10. Patients with symptomatic coronary disease or history of heart failure.
    11. An advanced, severe, or unstable disease of any type that may interfere with primary and secondary variable evaluations, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree ot put the patient at special risk.
    12. Patients receiving moderate/strong opioids (e.g. morphine, tramadol, oxycontine), carbamazepine and lidoderm patech during 1 month prior to randomisation.
    13. Patients who have a history of alcohol or drug abuse within the past year, or evidence of abuse through positive urine drug screen, if not proven to be derived from previously stopped intake of opiates.
    14. Patients who have used cannibis or derivatives within the past 6 months, unless these products were used successfully for pain relief, in which case they will need to be discontinued one month prior to randomisation.
    15. Patients known to be hypersensitive to the inredients of the SAB378 capsule, or to cannabinoid agonists.
    16. Patient who have received an experimental treatment within the past month.
    17. Patients who have a history of poor compliance or are unlikely to comply with medical regimens or study requirements.
    18. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, including localised basal cell carcinoma of the skin.
    19. Patients who foresee intensive UV exposure during the study (such as solar exposure on the beach, mountain sports, UV radiation by suntan lamps) or those with inherent sensitivity to sun.
    E.5 End points
    E.5.1Primary end point(s)
    11-point Numerical Rating Scale
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 88
    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 Decision2005-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-05
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 09 14:32:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA