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    Summary
    EudraCT Number:2004-001680-22
    Sponsor's Protocol Code Number:ROF102100
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-09-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-001680-22
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety and efficacy of controlled-release ropinirole (CR) (1-24mg) administered once daily for 12 weeks in subjects with fibromyalgia.
    A.4.1Sponsor's protocol code numberROF102100
    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 SponsorGlaxoSmithKline Research & Development Ltd.
    B.1.3.4CountryUnited Kingdom
    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 nameRopinirole Controlled Release (CR) Tablets
    D.3.2Product code SKF-101468
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNropinirole
    D.3.9.1CAS number 91374-20-8
    D.3.9.2Current sponsor codeSKF-101468
    D.3.9.3Other descriptive nameropinirole hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number1, 2, 3, 4 and 8
    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 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 placeboProlonged-release tablet
    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
    Fibromyalgia syndrome (FMS).
    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 analgesic efficacy of oral ropinirole controlled release formulation (CR) compared to placebo over a dose range in adult subjects with FMS as measured by the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
    E.2.2Secondary objectives of the trial
    1.To evaluate the safety and tolerability of ropinirole (CR) over a dose range in subjects with FMS
    2.To further evaluate the efficacy of ropinirole (CR) over a dose range in terms of:
    - Pain intensity
    - Proportion of responders
    - Patient and Clinician Global Impression of Change
    - Pain relief
    - Pain severity and its impact on daily functioning
    - Tender point assessment
    - Fibromyalgia Impact Questionnaire
    - Sleep quality
    - Rescue medication
    - Time to onset of analgesic effect
    3. To evaluate the effect of ropinirole (CR) on health-related quality of life outcomes, including physical and emotional functioning.
    4. To describe the pharmacokinetics of ropinirole in subjects with FMS following oral administration of ropinirole CR.
    5. To explore any relationship between systemic exposure to ropinirole and clinical outcome in subjects with FMS.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Subject is a male or female outpatient, at least 18 years of age.
    A female is eligible to enter and participate in the study if she is of:
    a Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
    b Childbearing potential, has a negative result on all required pregnancy tests prior to randomization, and agrees to an acceptable contraceptive method as defined in the protocol.
    2. Subject has a diagnosis of fibromyalgia as confirmed by the American College of Rheumatology (ACR) criteria.
    3. Subject has baseline PI-NRS score averaging greater than or equal to 4 during the week prior to randomization (Baseline Period) and at least four pain intensity observations are recorded during the 7 days of the Baseline Period.
    4. Subject is considered clinically appropriate for therapy with ropinirole based upon the Investigator’s overall clinical evaluation.
    5. Subject is in good general health apart from fibromyalgia, as determined by the Investigator (based upon the physical and laboratory examinations, ECG and medical history).
    6. Subject is able to comprehend the study procedures and schedule and is able to comply with study requirements.
    7. Subject has given informed consent prior to participation in the study. The contents and process of obtaining informed consent will be in accordance with all applicable regulatory requirements.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Other chronic pain condition(s) not associated with FMS.
    2. Unable to discontinue prohibited medications administered for the relief of pain of FMS or for depression and known to induce drowsiness for the required washout period and throughout the study.
    3. Subject has had non-drug therapies for fibromyalgia (such as herbal or holistic medications) or any other special procedures for fibromyalgia (e.g. TENS, acupuncture) within two weeks prior to the time of randomisation or will not be able to forgo these therapies/procedures during the study. Stable exercise regimens may be continued if subjects have been on them for at least 2 weeks prior to the randomisation.
    4. Known history of hypersensitivity or intolerance to acetaminophen/paracetamol.
    5. Withdrawal, introduction, or change in dose of HRT and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, Hormone Replacement Therapy) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment.
    6. Taking any medication with the potential for pharmacokinetic interaction with ropinirole.
    7. Prior exposure to ropinirole during a previous clinical trial for any indication.
    8. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than FMS), or cardiovascular disease or active malignancy (other than basal cell cancer)
    9. Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG.
    10. Subject has any clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG, which in the opinion of the investigator, could interfere with the interpretation of efficacy or safety data, or which otherwise would contraindicate participation in a clinical study.
    11. ECG or clinical evidence of atrial or ventricular hypertrophy; intraventricular conduction defects (excluding incomplete right bundle branch block in the absence of clinical evidence of heart disease); symptomatic coronary artery disease (or any symptomatic cardiac disease); myocardial strain, ischaemia, or infarct; atrial arrhythmia (must be in normal sinus rhythm); second- or third-degree AV block; congestive heart failure; cor pulmonale; or any cardiac condition that the investigator feels may predispose the subject to ischaemia or arrhythmia
    Subject has symptoms of a major depressive episode or active significant psychiatric disorders. Subjects with a history of depression that has required ongoing, current treatment with antidepressants are excluded.
    12. History of clinically significant drug or alcohol abuse as defined by DSM-IV or is unable to refrain from substance abuse throughout the study.
    13. Use of any investigational drug within 4 weeks (or 5 half-lives, whichever is longer) prior to the Screening Visit or is currently participating in another clinical study in which the subject is or will be exposed to an investigational or non-investigational drug or device.
    14. History of hypersensitivity or intolerance to ropinirole or associated excipients or dopamine.
    15. Pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    Change in pain intensity score from baseline (average of the Baseline Phase pain intensity scores) to the last week of treatment (Week 12), measured by the 11 point Pain Intensity Numerical Rating Scale (PI-NRS).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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 Information not present in EudraCT
    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) 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
    Last subject last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2004-09-17. Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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 Decision2004-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-07-01
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