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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2020-005165-14
    Sponsor's Protocol Code Number:TK-254R-0201
    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:2021-01-11
    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 number2020-005165-14
    A.3Full title of the trial
    Randomized, controlled, double-blind, multi-center trial to evaluate the
    Randomisierte, kontrollierte, doppelblinde, multizentrische Studie zur Bewertung der Wirksamkeit und Sicherheit eines Esflurbiprofen-Hydrogelpflasters im Vergleich zu Placebo bei der lokalen symptomatischen und kurzfristigen Behandlung von Schmerzen bei akuten Zerrungen, Verstauchungen oder Prellungen der Extremitäten nach einem stumpfen Trauma , z.B Sportverletzungen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate efficacy and safety of an Esflurbiprofen Hydrogel Patch vs. placebo in the local symptomatic and short-term treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries
    Eine Studie zur Bewertung der Wirksamkeit und Sicherheit eines Esflurbiprofen-Hydrogelpflasters im Vergleich zu Placebo bei der lokalen symptomatischen und kurzfristigen Behandlung von Schmerzen bei akuten Zerrungen, Verstauchungen oder Prellungen der Extremitäten nach einem stumpfen Trauma , z.B Sportverletzungen.
    A.4.1Sponsor's protocol code numberTK-254R-0201
    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 SponsorTeikoku Seiyaku Co Ltd.
    B.1.3.4CountryJapan
    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 supportTeikoku Seiyaku Co Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinsearch GmbH
    B.5.2Functional name of contact pointElke Klimmeck
    B.5.3 Address:
    B.5.3.1Street AddressZugerstr. 80A
    B.5.3.2Town/ cityWalchwill
    B.5.3.3Post code6318
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41417116376
    B.5.5Fax number41417111977
    B.5.6E-maile.klimmeck@clinsearch.de
    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 nameEsflurbiprofen hydrogel patch
    D.3.2Product code EFHP 165 mg
    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 INNesflurbiprofen
    D.3.9.1CAS number 5104-49-4
    D.3.9.2Current sponsor codeEsflurbiprofen
    D.3.9.3Other descriptive nameFLURBIPROFEN
    D.3.9.4EV Substance CodeSUB07745MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number165
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute strains, sprains or bruises of the extremities following blunt trauma
    Akute Zerrungen, Verstauchungen oder Prellungen der Extremitäten nach einem stumpfen Trauma
    E.1.1.1Medical condition in easily understood language
    Acute strains, sprains or bruises of the extremities following blunt trauma
    Akute Zerrungen, Verstauchungen oder Prellungen der Extremitäten nach einem stumpfen Trauma
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002549
    E.1.2Term Ankle sprain
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002550
    E.1.2Term Ankle sprains and strains
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028338
    E.1.2Term Muscle sprains
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028361
    E.1.2Term Muscular pain
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10028362
    E.1.2Term Muscular pains
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10006502
    E.1.2Term Bruise
    E.1.2System Organ Class 100000004863
    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 of a Esflurbiprofen 165 mg Hydrogel Patch applied once a day compared with placebo in patients with acute blunt, soft tissue injuries of the limbs.
    • The primary efficacy outcome is pain-on-movement (POM) change from baseline assessed by Visual Analogue Scale (VAS) to Visit 5 (72 hours after initiating treatment).
    • Important secondary efficacy outcomes are POM on VAS at Visit 2, 3, 4, 6 and 7 (12, 24, 48, 96 and 168 hours after initiating treatment).
    Um die Wirksamkeit eines Esflurbiprofen 165 mg Hydrogel-Pflasters zu bewerten, das einmal täglich im Vergleich zu Placebo bei Patienten mit akuten stumpfen Weichteilverletzungen der Gliedmaßen angewendet wird.
    • Das primäre Wirksamkeitsergebnis ist die Änderung des Schmerz-beim-Bewegung-Werts (POM) vom Ausgangswert, der anhand der visuellen Analogskala (VAS) ermittelt wurde, bei Besuch 5 (72 Stunden nach Beginn der Behandlung).
    • Wichtiges sekundäre Wirksamkeitsergebnis ist POM der VAS bei Besuch 2, 3, 4, 6 und 7 (12, 24, 48, 96 und 168 Stunden nach Beginn der Behandlung).
    E.2.2Secondary objectives of the trial
    To assess the safety of Esflurbiprofen Hydrogel Patch compared with placebo applied once a day for up to seven days.
    Zur Beurteilung der Sicherheit von Esflurbiprofen Hydrogel Patch im Vergleich zu Placebo, das bis zu sieben Tage lang einmal täglich angewendet wird.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
    2. location of injury such that pain-on-movement (POM) is elicited on by the exercises described in Section 7.5
    3. enrollment within 6 hours of the injury
    4. baseline VAS score for POM of injured extremity > 50 mm on a 100 mm VAS
    5. size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
    6. adult male or female patients
    7. age 18 to 60 years
    8. having given written informed consent
    9. satisfactory health as determined by the Investigator based on medical history and physical examination.
    10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
    • Surgical sterilization
    • Hormonal contraception
    • IUD
    • Double barrier method
    Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the study.
    A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    11. known hypersensitivity to Esflurbiprofen or one of the excipients of the patch
    12. patients with any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of Esflurbiprofen
    13. history of previous significant injury to the same extremity within 6 months
    14. patients with a disease affecting the same limb, such as synovitis, rheumatoid arthritis, arthrosis, etc.
    15. patients having an ongoing painful condition associated with sports-related injury/contusion
    16. patients suffering from symptoms of an infectious disease including swelling of any joint of the affected upper or lower limbs
    17. patients who had surgery of the affected upper or lower limb within one year of study entry
    18. patients with significant diseases (defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient’s ability to participate in the study; includes patients with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease).
    19. patients with a blood coagulation disorder
    20. patients who use any impermissible medication

    • akute sportbedingte Weichteilverletzung / -kontusion (Zerrungen, Verstauchungen, BPrellungen) der oberen oder unteren Extremität
    • Ort der Verletzung, so dass bei passiver Manipulation des nächsten Gelenks durch den Untersucher Schmerz bei Bewegung (POM) ausgelöst wird
    • Einschluss innerhalb von 6 Stunden nach der Verletzung
    • Basis-VAS-Score für POM der verletzten Extremität> 50 mm auf einer 100 mm VAS
    • vom Prüfer festgestellte Verletzungsgröße ≥ 25 cm2 und ≤ 120 cm2
    • erwachsene männliche oder weibliche Patienten
    • 18 bis 60 Jahre alt
    • eine schriftliche Einverständniserklärung wurde abgegeben
    • zufriedenstellende Gesundheit, wie vom Prüfer anhand der Krankengeschichte und der körperlichen Untersuchung festgestellt
    E.4Principal exclusion criteria
    1. significant concomitant injury in association with the index acute sports-related soft-tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
    2. excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
    3. current skin disorder or shaving hair at application site
    4. history of excessive sweating/hyperhidrosis inclusive of application site
    5. intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
    6. intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
    7. participation in a clinical study within 30 days before inclusion in the study or concomitantly
    8. drug or alcohol abuse in the opinion of the investigator
    9. Pregnant and lactating women
    10. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
    • Surgical sterilization
    • Hormonal contraception
    • IUD
    • Double barrier method
    • Total abstinence throughout the study at the discretion of the Investigator.
    • signifikante Begleitverletzung in Verbindung mit dem Stichwort akute sportbedingte Weichteilverletzung / -kontusion; z.B. Fraktur, Nervenverletzung, Bandstörung, Muskel- oder Knorpelriss oder offene Wunde
    • Übermäßig haarige Haut an der Applikationsstelle. Wenn Sie die Haare an der verletzten Stelle vor der Anwendung des Pflasters schneiden, dürfen sie einschließen
    • aktuelle Hauterkrankung oder Rasur der Haare an der Applikationsstelle
    • Vorgeschichte von übermäßigem Schwitzen / Hyperhidrose einschließlich an der Applikationsstelle
    • Einnahme von NSAIDs oder Analgetika innerhalb von 36 Stunden, Opioiden innerhalb von 7 Tagen oder Kortikosteroiden innerhalb von 60 Tagen vor Aufnahme in die Studie
    • Einnahme langwirksamer NSAIDs oder Anwendung topischer Medikamente seit der Verletzung (RICE erlaubt)
    • Teilnahme an einer klinischen Studie innerhalb von 30 Tagen vor Aufnahme in die Studie oder gleichzeitig
    • Drogen- oder Alkoholmissbrauch nach Meinung des Prüfarztes
    • schwangere und stillende Frauen
    • Frauen im gebärfähigen Alter ohne medizinisch akzeptierte Empfängnisverhütung
    • bekannte Überempfindlichkeit gegen Esflurbiprofen oder einen der Hilfsstoffe des Pflasters
    • Patienten mit anhaltenden Erkrankungen, die die Absorption, Verteilung, den Metabolismus oder die Ausscheidung von Esflurbiprofen beeinträchtigen können
    • Vorgeschichte einer früheren signifikanten Verletzung derselben Extremität innerhalb von 6 Monaten
    • Patienten mit einer Krankheit, das dasselbe Gliedmaß betrifft, wie Synovitis, rheumatoide Arthritis, Arthrose usw.
    • Patienten mit einem anhaltenden schmerzhaften Zustand, der mit sportbedingten Verletzungen / Quetschungen verbunden ist
    • Patienten, die an Symptomen einer Infektionskrankheit leiden, einschließlich einer Schwellung eines Gelenks der betroffenen oberen oder unteren Extremitäten
    • Patienten, bei denen die betroffene obere oder untere Extremität innerhalb eines Jahres vor Studienbeginn operiert wurde
    • Patienten mit schwerwiegenden Krankheiten (definiert als eine Krankheit, die nach Ansicht des Prüfers entweder den Patienten aufgrund der Teilnahme an der Studie gefährden kann oder eine Krankheit, die die Ergebnisse der Studie oder die Fähigkeit des Patienten zur Teilnahme beeinflussen kann; inklusive Patienten mit gastrointestinalen Blutungen in der Vorgeschichte, signifikanten Herz-Kreislauf-, Leber- oder Nierenerkrankungen.
    • Patienten mit einer Blutgerinnungsstörung
    • Patienten, die unzulässige Medikamente einnehmen

    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in pain-on-movement (POM) at injured site in mm measured using a 100 mm Visual Analogue Scale (VAS) to Visit 5 (72 hours after commencement of study treatment)
    Änderung des Schmerz-bei-Bewegung-Werts (POM) an der verletzten Stelle in mm, gemessen mit einer 100-mm-VAS (Visual Analogue Scale), zu Besuch 5 (72 Stunden nach Beginn der Studienbehandlung).
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours after commencement of study treatment
    72 Stunden nach Beginn der Studienbehandlung
    E.5.2Secondary end point(s)
    • POM at injured site in mm measured using a 100 mm VAS at 12, 24, 48, 72, 96 and 168 hours after commencement of study treatment
    • AUC over time during first 24, 48, 72 and 96 hours for POM measured using a VAS; ordinate = POM score in mm, abscissa = time after treatment
    • Pain-at-rest (PAR) at injured site in mm measured using a 100 mm VAS at 12, 24, 48, 72, 96 and 168 hours
    • Reduction in VAS for POM from baseline:
    o Time to meaningful reduction (30%)
    o Time to optimal reduction (50%)
    o Time to complete resolution of pain
    • Responder rate 1 (defined as the proportion of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours)
    • Responder rate 2 (defined as the proportion of patients able to resume training / normal physical activity by 168 hours)
    • Clinical global assessment of efficacy as judged by investigator and patient at 48, 72 and 168 hours
    • Overall dose of rescue medication needed (paracetamol)

    Other:
    • Adhesive power of patch (5-point scale)
    • If there is significant use of rescue medication, a sensitivity analysis may be performed to assess impact on primary endpoint and responder rate.
    • POM an der verletzten Stelle in mm, gemessen mit einem 100 mm VAS 12, 24, 48, 72, 96 und 168 Stunden nach Beginn der Studienbehandlung
    • AUC über die Zeit während der ersten 24, 48, 72 und 96 Stunden für POM, gemessen mit einem VAS; Ordinate = POM-Score in mm, Abszisse = Zeit nach der Behandlung
    • Schmerz in Ruhe (PAR) an der verletzten Stelle in mm, gemessen mit einem 100 mm VAS nach 12, 24, 48, 72, 96 und 168 Stunden
    • Reduzierung des VAS für POM gegenüber dem Ausgangswert:
    o Zeit bis zu einer sinnvollen Reduzierung (30%)
    o Zeit bis zur optimalen Reduzierung (50%)
    o Zeit, um die Schmerzlinderung abzuschließen
    • Responder-Rate 1 (definiert als der Anteil der Patienten, die nach 72 Stunden eine Reduktion des VAS-Scores für POM um ≥ 50% gegenüber dem Ausgangswert erreichen)
    • Responder-Rate 2 (definiert als der Anteil der Patienten, die das Training / die normale körperliche Aktivität um 168 Stunden wieder aufnehmen können)
    • Klinische globale Bewertung der Wirksamkeit nach Beurteilung durch den Prüfer und den Patienten nach 48, 72 und 168 Stunden
    • Erforderliche Gesamtdosis an Rettungsmedikamenten (Paracetamol)

    Andere:
    • Haftkraft des Pflasters (5-Punkte-Skala)
    • Wenn Rettungsmedikamente in erheblichem Umfang eingesetzt werden, kann eine Sensitivitätsanalyse durchgeführt werden, um die Auswirkungen auf den primären Endpunkt und die Responder-Rate zu bewerten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 24, 48, 72, 96 and 168 hours after commencement of study treatment
    12, 24, 48, 72, 96 und 168 Stunden nach Beginn der Studienbehandlung
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    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
    Last Visit Last Subject
    Letzter Besuch Letzter Teilnehmer
    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 months6
    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 months6
    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: 200
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    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 state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    None
    Keins
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-06
    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 03 23:03:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA