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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2010-023207-10
    Sponsor's Protocol Code Number:S+M/10/10
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-31
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-023207-10
    A.3Full title of the trial
    A multicentre, randomized, open label, parallel group pilot study comparing efficacy and safety of sufentanil transdermal delivery system (TDS) to oral sustained release morphine sulphate in patients with chronic cancer pain
    Multicentrická, randomizovaná, otvorená, pilotná 4 týždňová štúdia s paralelnými skupinami na stanovenie účinnosti a bezpečnosti sufentanilu v transdermálnom aplikačnom systéme (TDS) a morfín sulfátu s predĺženým uvoľňovaním u pacientov s chronickou nádorovou bolesťou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicentre, randomized, open label, parallel group pilot study comparing efficacy and safety of sufentanil transdermal delivery system (TDS) to oral sustained release morphine sulphate in patients with chronic cancer pain
    Multicentrická, randomizovaná, otvorená, pilotná 4 týždňová štúdia s paralelnými skupinami na stanovenie účinnosti a bezpečnosti sufentanilu v transdermálnom aplikačnom systéme (TDS) a morfín sulfátu s predĺženým uvoľňovaním u pacientov s chronickou nádorovou bolesťou
    A.3.2Name or abbreviated title of the trial where available
    S+M/10/10
    A.4.1Sponsor's protocol code numberS+M/10/10
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorhameln rds a.s.
    B.1.3.4CountrySlovakia
    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 supporthameln rds, a.s.
    B.4.2CountrySlovakia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationhameln rds, a.s.
    B.5.2Functional name of contact pointUwe Risse
    B.5.3 Address:
    B.5.3.1Street AddressHorná 36
    B.5.3.2Town/ cityModra
    B.5.3.3Post code900 01
    B.5.3.4CountrySlovakia
    B.5.4Telephone number+421336904402
    B.5.5Fax number+421336904401
    B.5.6E-mailu.risse@hameln-rds.com
    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 No
    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 nameSufentanil TDS (0,75mg/3cm2)
    D.3.2Product code Sufentanil TDS
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSufentanil
    D.3.9.1CAS number 56030-54-7
    D.3.9.2Current sponsor codeS
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 MST Continus®
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMST Continus
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Ophthalmic use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.9.1CAS number 64313
    D.3.9.2Current sponsor codeM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.9.1CAS number 64313
    D.3.9.2Current sponsor codeM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.9.1CAS number 64313
    D.3.9.2Current sponsor codeM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.9.1CAS number 64313
    D.3.9.2Current sponsor codeM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    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 Sevredol®
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameSevredol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate pentahydrate
    D.3.9.1CAS number 6211-15-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Chronic cancer pain
    Chronická malígna bolesť
    E.1.1.1Medical condition in easily understood language
    Chronic pain associated with malignant diseases
    Chronická bolesť spojená s malígnymi ochoreniami
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10058019
    E.1.2Term Cancer pain
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 compare the consumption (mg) of rescue analgesia (immediate release morphine sulfate tablets) per day after the administration of sufentanil TDS to its consumption after the administration of SR morphine sulfate (during the maintenance period (Visit 9 to 13)).
    Primárnym cieľom tejto štúdie je porovnanie dennej spotreby (mg) záchrannej liečby (tablety morfín-sulfátu s rýchlym uvoľňovaním) pri podávaní sufentanilu TDS so jeho spotrebou pri podávani SR morfín-sulfátu (počas udržiavacieho obdobia (Návšteva 9 až 13)).
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives of this study are to evaluate:
    • Rescue analgesic use (doses/day and time of day)
    • Pain intensity (0-10 numerical scale)
    • Incidence and time (days) to withdrawal due to lack of efficacy
    • Sedation (0-10 numerical scale)
    • Nausea (0-10 numerical scale)
    • Constipation (0-10 numerical scale)
    • Investigators and patient’s global assessment of response to therapy
    • Quality of life assessment (EORTC)
    The secondary safety objectives of this study are to evaluate:
    • adverse events
    • local tolerance
    • vital signs
    • clinical laboratory evaluations
    • 12-lead ECG
    Sekundárnymi cielmi účinnosti tejto štúdie sú:
    • Použitie záchrannej analgézie (dávky/deň a denná doba)
    • Intenzita bolesti (0-10 číselná škála)
    • Incidencia a čas (dni) po odstúpenie pre nedostatočný účinok
    • Sedácia (0-10 číselná škála)
    • Nauzea (0-10 číselná škála)
    • Zápcha (0-10 číselná škála)
    • Celkové zhodnotenie odpovede na liečbu skúšajúcim a pacientom
    • Zhodnotenie Kvality života (EORTC)
    Sekundárnymi cieľmi bezpečnosti tejto štúdie sú:
    • nežiaduce príhody
    • lokálna tolerancia
    • vitálne funkcie
    • klinické laboratórne vyšetrenia
    • 12-zvodové EKG
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic sub-study (implemented in main protocol), 03.12.2010, version 01, final
    E.3Principal inclusion criteria
    Male or female patients aged 18 to 75 with a diagnosis of cancer;
    Documented history of moderate to severe chronic cancer pain requiring around-the-clock therapy and are likely to benefit from WHO step III opioid analgesics for the duration of the study;
    Stable but inadequately controlled pain (with present breakthrough pain attacks) with current therapy for at least two weeks;
    Pain intensity, as assessed by the pain intensity numerical rating scale during Visit 1, meets the definition of „moderate“ (score of 4-5) or „severe“ (score of 6-10) pain;
    Life expectancy of more than 3 months;
    Male, or female patients with childbearing potential who must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation;
    Ability to understand and willingness to sign a written informed consent.
    E.4Principal exclusion criteria
    Known hypersensitivity or intolerance to opioid analgesics or any excipient of the investigational products;
    Planned initiation of chemotherapy, radiotherapy, or bisphosphonates treatment during the course of the study or within 30 days prior to randomization;
    Scheduled elective surgery or other invasive procedures during the period of study participation;
    Received an investigational drug within 30 days prior to screening or who is scheduled to receive an other investigational drug during the course of the study;
    Any ongoing serious adverse events (SAEs) at screening;
    Respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, (obstructive) sleep apnea syndrome, paralytic ileus;
    Known history of uncontrolled seizures, increased intracranial pressure;
    Evidence of clinically significant cardiovascular, renal, hepatic, CNS or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the results;
    Abnormal laboratory findings during screening (these patients will be not randomized): aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT) levels more than 3 times the upper level of normal; total bilirubin level more than 1.5 times the upper level of normal creatinine clearance less than 50 ml/min (calculated using the Cockcroft-Gault formula);
    Patients who are receiving hypnotics or other central nervous system (CNS) depressants that, in the opinion of the investigator, may pose a risk of additional CNS depression with opioid medication;
    Taking lidocaine, mexiletine or other anaesthetics;
    Use of scopolamine, acetylcholinesterase-inhibiting drugs, beta-blockers and antiarrythmic drugs;
    Patients with myxoedema, inadequately controlled hypothyroidism or Addisons disease;
    Active skin disease;
    Patients suffering from diarrhea and/or opioid withdrawal;
    Known positive Hepatitis B or C or HIV status;
    History of alcohol and/or drug abuse within one year preceding the Screening Visit;
    Patients who are pregnant, breast feeding or women of childbearing potential. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of reproductive potential, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following termination of the study.
    Is an employee of the investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of the employees or the investigator.
    Unwilling or unable to comply with the protocol
    Any other condition that, in the opinion of the investigator, is likely to interfere with the successful collection of the measures required for the study or poses a risk to the patient.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the consumption (mg) of rescue analgesia (immediate release morphine sulfate tablets) per day during the maintenance period (Visit 9 to Visit 13).
    The ITT population will be considered primary for the efficacy analyses and comprises of all randomized patients who receive at least 1 dose of study treatment.
    Data will be summarized and analyzed descriptively and graphically for the primary endpoint, each 24-hour period, and each 4-hour period. Differences between the treatment groups with 95% confidence intervals will be calculated using appropriate parametric and/or non-parametric methods.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study, no interim analysis is planned
    E.5.2Secondary end point(s)
    The secondary efficacy objectives of this study are to evaluate:
    • Rescue analgesic use (doses/day and time of day)
    • Pain intensity (0-10 numerical scale)
    • Incidence and time (days) to withdrawal due to lack of efficacy
    • Sedation (0-10 numerical scale)
    • Nausea (0-10 numerical scale)
    • Constipation (0-10 numerical scale)
    • Investigators and patient’s global assessment of response to therapy
    • Quality of life assessment (EORTC)
    The secondary safety objectives of this study are to evaluate:
    • adverse events
    • local tolerance
    • vital signs
    • clinical laboratory evaluations
    • 12-lead ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study, no interim analysis is planned
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    pilot
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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 No
    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
    Study participation will be normally finished at Visit 14, in case of premature withdrawal all procerudes described for the Visit 13 will be performed. Afterwards patients treatment will be in discretion of the investigators.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    Routine treatment used by physicians
    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 Decision2011-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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