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    Summary
    EudraCT Number:2006-006291-38
    Sponsor's Protocol Code Number:06-010
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2006-006291-38
    A.3Full title of the trial
    A Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia
    A.4.1Sponsor's protocol code number06-010
    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 SponsorJazz Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Xyrem(R)
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Oral solution
    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 502852
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive nameSODIUM OXYBATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fibromyalgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the safety of Xyrem (sodium oxybate) in long term use (up to 38 weeks) in subjects completing a double-blind controlled trial of Xyrem for the treatment of fibromyalgia.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to: 1) evaluate the long-term efficacy of open-label Xyrem in subjects with fibromyalgia, and 2) assess the long-term effects of open-label Xyrem on quality of life, social and occupational functioning, sleep, and daytime fatigue in subjects with fibromyalgia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has completed Jazz Pharmaceuticals, Inc., Study 06-008 or Study 06-009 within the past 7 days.
    2. Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9.5 months and complete all tests and visits described in this protocol.
    3. Subject is able to understand the written informed consent and has signed and dated the consent prior to beginning protocol-required procedures.
    4. Female subjects may be included if they have a negative urine pregnancy test at study entry.
    5. Female subjects of child-bearing potential and peri-menopausal subjects must agree to use a medically acceptable method of birth control while enrolled in the study. Acceptable methods include approved oral or implanted hormonal contraceptive therapy, intrauterine devices, contraceptive patch, abstinence, and “double barrier” methods.
    6. Subject must be willing to refrain from the use of any medications, herbal remedies, and/or devices being used to treat his/her fibromyalgia symptoms until trial completion. Such medications include but are not limited to: opiates, benzodiazepines, muscle relaxants, cyclobenzaprine (Flexeril®), anticonvulsants, antidepressants, dopamine agonists and/or tramadol (Ultram®).
    7. Subject agrees to use only ibuprofen (up to 1,200 mg/day), naproxen (up to 660 mg/day), or acetaminophen(paracetamol) (up to 4 g/day) as rescue pain medication. (Simultaneous use of acetaminophen(paracetamol) and either ibuprofen or naproxen is permitted. Simultaneous use of ibuprofen and naproxen will not be allowed on the same day during the study.)
    8. Subject is willing to not drink alcohol for the duration of the trial.
    E.4Principal exclusion criteria
    1. Subject experienced any serious adverse event (SAE) that was related to study drug during participation in Jazz Pharmaceuticals, Inc., Protocol 06-008 or 06-009.
    2. Subject, in the opinion of the investigator, experienced an AE in Protocol 06-008 or 06-009 that may prevent him/her from safely participating in and completing the current study.
    3. Subject terminated early from Study 06-008 or 06-009.
    4. Subject has any new condition, physical examination finding, or laboratory test result that, in the opinion of the investigator, could impact subject safety, could interfere with the evaluation of the subject, or affect subject’s compliance with the protocol requirements.
    5. Subject developed a current primary diagnosis of major depressive disorder, psychotic disorder, and/or bipolar disorder (DSM-IV-TR).
    6. Subject is, in the opinion of the investigator, a suicidal or homicidal risk; or subject scored ≥1 on Question 9 of the BDI-II (see Appendix X) at Visit 1 or any time during the 06-008 or 06 009 study.
    7. Subject is pregnant, nursing, or lactating.
    8. Subject has an abnormal pretrial (within 7 days of Visit 1 in this study) ECG result that in the opinion of the investigator is clinically significant.
    9. Subject has a positive urine drug screen for benzodiazapines or other drugs of abuse and/or a positive alcohol test and/or a history of substance abuse (Appendix XII).
    10. Subject is diagnosed with sleep apnea and not currently on stable continuous positive airway pressure (CPAP) therapy, or the investigator judges that the subject’s risk of sleep apnea has increased during the double-blind study 06-008 or 06-009.
    11. Subject has begun or plans to begin shift-work or another responsibility, activity, or schedule that, in the opinion of the investigator, could impact subject safety or affect the subject’s compliance with protocol requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Two primary efficacy parameters (1 and 2) will be evaluated.
    The first is a composite parameter for the treatment of pain associated with fibromyalgia. The proportion of subjects who meet both of the following response criteria will be summarized:
    • Overall pain severity will be assessed by pain VAS data recorded each evening by the subject in an electronic diary. For pain VAS, a response is defined as a reduction in average pain of ≥20% from prior study baseline.
    • Patient Global Impression of Change. The subject's perception of the overall improvement in his/her fibromyalgia symptoms compared to prior study baseline will be assessed by means of the PGIc questionnaire. A response to treatment is defined as a response of “Very much better” or “Much better” on the PGIc.

    The second parameter is a composite parameter for the treatment of fibromyalgia syndrome. The proportion of subjects who meet all three of the following response criteria will be summarized.
    • Overall pain severity will be assessed by pain VAS data recorded each evening by the subject in an electronic diary. For pain VAS, a response is defined as a reduction in average pain of ≥ 20% from prior study baseline.
    • Functionality (Fibromyalgia Impact Questionnaire). A response will be defined as a reduction of ≥20% in FIQ total score from prior study baseline. For example, if a subject has a prior study baseline FIQ score of 40, he/she will need to have an FIQ score of 32 or less to be considered a responder.
    • Patient Global Impression of Change. The subject’s perception of the overall improvement in his/her fibromyalgia symptoms compared to prior study baseline will be assessed by means of the PGIc questionnaire. A response to treatment is defined as a response of “Very much better” or “Much better” on the PGIc
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 No
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 1050
    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)
    Subjects who had on-going adverse events at the time of study completion will be contacted by telephone 30 days after their last dose of study medication to assess resolution of symptoms.
    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 Decision2009-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-22
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