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    Summary
    EudraCT Number:2004-003937-14
    Sponsor's Protocol Code Number:A-92-52030-164
    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:2005-09-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-003937-14
    A.3Full title of the trial
    A phase II, unicentre, randomized, double-blind, parallel and placebo-controlled, pilot study to evaluate the efficacy and safety of Somatuline Autogel (60 mg) in patients with active thyroid-associated ophthalmopaty of moderate intensity. Estudio piloto, de fase II, unicéntrico, aleatorizado, a doble ciego, paralelo y controlado con placebo para evaluar la eficacia y seguridad de Somatulina Autogel R (60 mg) en pacientes con oftalmopatía tiroidea activa de intensidad moderada
    A.4.1Sponsor's protocol code numberA-92-52030-164
    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 SponsorIPSEN PHARMA, S.A
    B.1.3.4CountrySpain
    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.2.1.1.1Trade name Somatulina Autogel ® 60 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN PHARMA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlanreotide
    D.3.9.2Current sponsor code52030
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active thyroid-associated ophtalmopathy of moderate intensity.
    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 and safety of 3 doses of Somatuline Autogel (60 mg) in the control of the infiltration and edema of the muscle and retrobulbar connective tissue and in the retraction and contraction of the extraocular musculature in patients with active thyroid-associated ophtalmopathy of moderate intensity.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - The patient must give written or oral (with witnesses) informed consent prior to any study-related procedure.
    - Patients from both genders and over 18 years of age
    - Patients with autoinmune thyroid disease and whose center's medical records confirm the presence of euthyroidism for at least two months before being included into the study.
    - Thyroid-associated ophtalmopathy diagnosed a minimum of six months before his/her participation in the study, well documented in the centre's medical records.
    - The intensity of thyroid-associated ophtalmopathy in the worst eye has to be moderate and based on the following criteria:
    Two or more of the following criteria:
    • Modified Clinical Activity Score (CAS)(1) 1-2
    • Subclinic optical neuropathy (abnormal visual evoked potentials)
    • Lid width incremented with superior sclerocorneal limbo and visible adjacent
    sclerotic
    • Inttermitent diplopia
    • Proptosis ≥20 mm and <21.5

    or

    One or more of the following criteria
    • Modified Clinical Activity Score 3-4
    • Visual acuity between 0.5 and 0.9 (both included)
    • Lid width incremented with superior sclerotic clearly visible and up to a maximum of 2 mm
    • Proptosis 21.5 to 23 mm
    • Occasional diplopia (with the gaze's secondary positions)

    (1) Modified CAS: each one of the following signs is considered as one point: spontaneous retrobulbar pain, pain in the eye movements, lid erythema, conjunctival hyperemia, chemosis, caruncle inflamation, oedema of the lid.

    • Patients whose ophtalmopathy activity has been demonstrated by a positive octreoscan.
    E.4Principal exclusion criteria
    - The patient presents compressive optical neuropathy signs or risk of corneal perforation which require immediate surgical treatment.
    - The patient presents thyroid-associated ophtalmopathy diagnosed as serious based on the following critera:
    • Modified CAS>4
    • Visual acuity <0.5
    • Lid width incremented with >2 mm of visible superior sclerotic
    • Proptosis>23 mm
    • Permanent diplopia with the gaze's primary position
    - The patient has been treated with radio-iodine for his/her thyroid disturbance within the 6 months previous to the inclusion in the trial.
    - The patient's thyroid-associated ophtalmopathy has been treated previously (except for drops and local measures) or he is scheduled to be treated during the study time (except for the study medication).
    - The patient is planned to be treated with radio-iodine or thyroidectomy for his/her Grave's disease during the study.
    - Myopia, glaucoma or any other eye disease which could modify the ophtalmologycal progress, such as cataracts or macule degeneration.
    - The patient is a smoker of more than 5 cigarettes per day.
    - the patient is included in other trial.
    - Breast-feeding or pregnant women (beta-HCG will be measured before the patients are included) or high risk of getting pregnant due to inadequate contraceptive measures.
    - Patients receiving any unlicensed drug within the 30 previous days to the start of the study.
    - Patients previously entered in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the oedema and the infiltration of the extraocular muscles and connective tissue measuring the extraocular muscle size by using orbital computerized tomography, to assess the proptosis by using a Hertel's exophthalmometer and measuring the intraocular pressure with a Perkin's tonometer.

    To assess the retraction and contraction of the extraocular musculature measuring the palpebral retraction assessed by the visual exam of the upper sclereocorneal limbo and visible adjacent sclerotic; and the function of the extraocular musculature evaluated by the Hess Weiss's diagram (for motility) and with the Maddox cross (for diplopia).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 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 visit of the last patient recruited in 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 months4
    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 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 state20
    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 Decision2005-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-27
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