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    EudraCT Number:2016-000943-14
    Sponsor's Protocol Code Number:OLT1177-05
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-07
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-000943-14
    A.3Full title of the trial
    A Phase 2 Single-Center, Proof-of-Concept Safety and Efficacy Study of Orally Administered OLT1177 Capsules with Successive, Result-Dependent Dose Adaptation in Subjects with an Acute Gout Flare
    Een fase 2, mono-centrische, proof-of-concept studie om de veiligheid en werkzaamheid te bepalen van oraal toegediende OLT1177 capsules in proefpersonen met een acute jichtaanval, waarbij resultaat-afhankelijk de dosis opeenvolgend wordt aangepast
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OLT1177 Capsules for the Treatment of Acute Gout Flare
    OLT1177 Capsules voor de behandeling van acute jichtaanval
    A.4.1Sponsor's protocol code numberOLT1177-05
    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 SponsorOlatec Therapeutics LLC
    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 supportOlatec Therapeutics LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOlatec Therapeutics LLC
    B.5.2Functional name of contact pointClinical Trials Inquiries
    B.5.3 Address:
    B.5.3.1Street Address800 Fifth Avenue, Suite 25D
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1212823-0241
    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 nameDapansutrile Capsules
    D.3.2Product code OLT1177 Capsules
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNdapansutrile
    D.3.9.1CAS number 54863-37-5
    D.3.9.2Current sponsor codeOLT1177
    D.3.9.3Other descriptive name3-methanesulfonyl-propionitrile
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Acute gout flare
    Acute jichtaanval
    E.1.1.1Medical condition in easily understood language
    Gout Flare
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018628
    E.1.2Term Gout acute
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of OLT1177 Capsule after oral administration in subjects with an acute gout flare
    Het beoordelen van de veiligheid en verdraagbaarheid van OLT1177 Capsule na orale toediening bij patiënten met een acute jichtaanval.
    E.2.2Secondary objectives of the trial
    To assess the clinical activity of various doses of OLT1177 Capsule in treating signs and symptoms resulting from an acute gout flare

    To assess OLT1177-induced changes in inflammatory biomarkers
    Het beoordelen van de klinische activiteit van verschillende doses van OLT1177 Capsule bij de behandeling van klachten en symptomen als gevolg van een acute jichtaanval.

    Het beoordelen van de OLT1177-geinduceerde veranderingen in ontstekingsbiomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and female subjects between 18 and 80 years old, inclusive
    2) Gout in a joint of a subject’s lower limbs (e.g. ankle, foot, knee, toe) as indicated by the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint and in accordance with ACR/EULAR 2015 Gout Classification Criteria
    3) Confirmation of a gout flare in the target joint that began within 96 hours prior to the Baseline visit, based on presence of subject-reported joint pain at rest of ≥ 50 mm on a 0 - 100 mm VAS and at least two of the following criteria in the target joint:
    a. Subject-reported flare
    b. Subject-reported warm joint
    c. Subject-reported swollen joint
    4) Acceptable overall medical condition to be safely enrolled in and to complete the study (with specific regard to cardiovascular, renal and hepatic conditions) in the opinion of the Investigator
    5) Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes abstaining from use of pain or Rescue Medication (for 12 hours after first dose of investigational drug) and other prohibited medications as outlined in Section 5.6.3 of the protocol.
    1) Mannen en vrouwen in de leeftijd van 18 tot en met 80 jaar.
    2) Jicht in een gewricht van de onderste ledematen (bv. enkel, voet, knie of teen) aangetoond door de aanwezigheid van mononatriumuraat (MSU) kristallen door microscopische evaluatie van synoviaal vocht uit het doelgewricht en in overeenstemming met ACR/EULAR 2015 Jicht Classificatie Criteria.
    3) Bevestiging van een jichtaanval in het doelgewricht welke binnen 96 uur voor de baseline visite begon, gebaseerd op de aanwezigheid van patiënt-gerapporteerde gewrichtspijn in rust van ≥ 50 mm op een 0 - 100 mm visueel analoge schaal (visual analog scale (VAS)) en tenminste twee van de volgende criteria in het doelgewricht:
    a. Patiënt gerapporteerde aanval
    b. Patiënt gerapporteerd warm gewricht
    c. Patiënt gerapporteerd gezwollen gewricht.
    4) Acceptabele algehele medische conditie om volgens de arts veilig geïncludeerd te kunnen worden en om de studie af te kunnen ronden (met specifieke aandacht voor cardiovasculaire, renale en hepatische condities)
    5) Het vermogen om schriftelijke toestemming te geven voor het initiëren van studie gerelateerde procedures en het vermogen, volgens de arts, om de studie te begrijpen en zich te houden aan alle eisen van de studie, inclusief onthouding van gebruik van pijn of reddingsmedicatie (gedurende 12 uur na inname van de eerste dosis onderzoeksmiddel) en andere verboden medicatie zoals aangegeven in sectie 5.6.3 van het protocol.
    E.4Principal exclusion criteria
    1) Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who:
    a. Are or intend to become pregnant (including use of fertility drugs) during the study
    b. Are nursing [female subjects only]
    c. Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete.
    2) Presence of an acute gout flare in more than one joint at the Baseline visit
    3) Presence of another inflammatory arthritis in addition to gout
    4) Presence or known history of other autoimmune conditions (e.g. systemic lupus erythematosus, hypophysitis, etc.)
    5) Clinically significant general pain or non-gout related joint pain that would interfere with the subject’s ability to accurately assess pain in the target joint, at the discretion of the Investigator
    6) Use of any prohibited concomitant medications/therapies over the periods defined in Section 5.6.3 or planned use of any concomitant medications/therapies during the Treatment Period (including the use of paracetamol within 4 hours prior to the Baseline visit or other pain medications within 12 hours prior to the Baseline visit)
    7) Active infection within 3 days prior to the Baseline visit
    8) History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
    9) Diagnosed with any form of internal cancer within the past 5 years
    10) Any other concomitant medical or psychiatric conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing protocol requirements
    11) History of alcohol or substance abuse within the 12 months prior to the Baseline visit
    12) Enrollment in any trial and/or use of any investigational product or device within the immediate 30-day period prior to the Baseline visit
    13) Enrollment in any study previously sponsored by Olatec Therapeutics LLC, specifically Study OLT1177-01, Study OLT1177-02, Study OLT1177-03 or Study OLT1177-04
    14) Known diagnosis of chronic kidney disease or known history of renal impairment (e.g. calculated glomerular filtration rate [GFR] less than 40 mL/min)
    1) Vrouwen in de vruchtbare leeftijd, of mannen die een vrouwelijke partner hebben in de vruchtbare leeftijd die:
    a. Zwanger zijn of zwanger proberen te worden (inclusief gebruik van vruchtbaarheidsmedicatie) tijdens de studie
    b. Borstvoeding geven [alleen voor vrouwelijke patiënten]
    c. Geen acceptabele, hoog effectieve vorm van anti-conceptie gebruiken totdat alle opvolgende procedures afgerond zijn. Zie sectie 5.6.2 voor meer details over acceptabele vormen van anti-conceptie.
    2) Aanwezigheid van een acute jichtaanval in meer dan één gewricht tijdens de baseline visite.
    3) Aanwezigheid van andere ontstekingsartritis naast jicht.
    4) Aanwezigheid of bekend met een geschiedenis van andere auto-immuun aandoeningen (bijvoorbeeld systemische lupus erythematosus, hypofisitis, enz.)
    5) Klinisch significante algemene pijn of niet jicht gerelateerde gewrichtspijn die, volgens de arts, de patiënt belemmert om nauwkeurig de pijn aan te kunnen geven in het doelgewricht.
    6) Gebruik van verboden co-medicatie/therapieën tijdens de periodes genoemd in sectie 5.6.3 of gepland gebruik van co-medicatie/therapieën gedurende de behandel periode (inclusief het gebruik van paracetamol in de 4 uur voor de baseline visite of andere pijn medicatie in de 12 uur voor de baseline visite).
    7) Actieve infecties binnen 3 dagen voor de baseline visite.
    8) Medische geschiedenis met of positief voor HIV, hepatitis B surface antigeen (HBsAg) of antilichamen tegen het hepatitis C virus (HCV).
    9) Diagnose met elke vorm van inwendige kanker in de afgelopen 5 jaren.
    10) Alle andere bijkomende medische of psychische aandoeningen, ziektes of eerdere operaties die, naar mening van de arts, de veilige deelname aan de studie en/of voldoen aan de protocol vereisten van patiënten kunnen belemmeren.
    11) Geschiedenis van alcohol of substantie misbruik in de 12 maanden voor de baseline visit.
    12) Deelname aan andere trials en/of gebruik van onderzoeksproducten of hulpmiddelen binnen de 30 dagen voor de baseline visite.
    13) Deelname aan andere eerder uitgevoerde studies, gesponsord door Olatec Therapeutics LLC, specifiek de studies OLT1177-01, OLT1177-02, OLT1177-03 of OLT1177-04
    14) Diagnose met chronische nierziekte of een medische geschiedenis met nierinsufficiëntie (b.v. berekende glomerulaire filtratie ratio [GFR] van minder dan 40 ml/min)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are those related to safety objective of the study, specifically:
    - Physical examination (abbreviated general and site specific examination)
    - Vital Signs (pulse, resting blood pressure, temperature, respiration rate)
    - Safety laboratory measures (chemistry, hematology and urinalysis)
    - Safety electrocardiograms (ECGs)
    - Adverse Events (AEs) during the clinical trial

    The primary clinical activity outcome will be:
    - Change in subject-reported pain intensity score from Baseline (Day 0) to Day 3 (evening; approximately 72 hours after the first dose) in the target joint (100-mm VAS)
    De primaire eindpunten zijn deze gerelateerd aan het veiligheidsdoel van de studie, in het bijzonder:
    - lichamelijk onderzoek (verkort algemeen en gebiedsspecifiek onderzoek);
    - vitale functies (pols, bloeddruk in rust, temperatuur, ademhalingsratio);
    - Laboratorium testen voor veiligheid (chemie, hematologie en urine analyse)
    - Electrocardiogram (ECG) voor veiligheid;
    - Bijwerkingen (AEs) gedurende de klinische studie;.

    Het primaire eindpunt voor klinische activiteit is:
    - De verandering in de patiënt-gerapporteerde pijnintensiteit score van Baseline (Dag 0) tot Dag 3 (avond; ongeveer 72 uur na de eerste dosis) in het doelwit gewricht (100-mm VAS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Physical examination: Baseline (pre-dose), Day 14
    - Vital Signs: Baseline (pre- and post-dose), Day 3, Day 7 and Day 14
    - Safety laboratory measures: Baseline (pre-dose), Day 3, Day 7 and Day 14
    - Safety electrocardiograms (ECGs): Baseline (pre-dose) and Day 7
    • Adverse Events (AEs): throughout clinical trial
    • Change in subject-reported pain intensity score in the target joint (100-mm VAS): Baseline & Day 3 (evening)
    - Lichamelijk onderzoek: baseline (pre-dosering), dag 14;
    - Vitale functies: baseline (pre- en post-dosering), dag 3, dag 7 en dag 14;
    - Laboratorium testen: baseline (pre-dosering), dag 3, dag 7 en dag 14;
    - ECG: baseline (pre-dosering) en dag 7;
    - Bijwerkingen (AEs): gedurende de klinische studie;
    - Verandering in patiënt-gerapporteerde pijn intensiteitsscore in het doelgewricht (100-mm VAS): baseline en dag 3 (avond).
    E.5.2Secondary end point(s)
    The principle secondary clinical activity outcomes will be:
    - Subject-reported global evaluation of treatment at Day 7 (Likert scale)

    The following secondary clinical activity variables will also be collected:
    - Subject-reported pain intensity score in the target joint (100 mm-VAS)
    - Subject-reported general disability score in the target joint (100 mm-VAS)
    - Subject-reported walking disability score in the target joint (100 mm-VAS)
    - Investigator-assessed Index Joint Score (tenderness, swelling, erythema, warmth)
    - Investigator-assessed Global Rating of Disease (Likert scale)
    - Blood levels of high sensitivity C-reactive protein (hsCRP) and Serum Amyloid A protein (SAA) and inflammatory cytokines
    - If at any time during the study a subject is unable to tolerate his/her pain and wishes to receive standard medical intervention for an acute gout flare, the subject will be withdrawn from the study, considered a Treatment Failure and treated with either prednisolone (30 mg QD) or colchicine (0.5 mg TID). In addition to the clinical activity variables described above, the number and proportion of Treatment Failures in each cohort will be captured and summarized in the study results.
    Het secundaire hoofdeindpunt van klinische activiteit is:
    - De patiënt-gerapporteerde globale evaluatie van de respons op Dag 7 (Likertschaal).

    De volgende secundaire klinische activiteitsvariabelen worden ook verzameld:
    - Patiënt-gerapporteerde pijn intensiteit in doelwit gewricht (100 mm-VAS)
    - Patiënt-gerapporteerde algemene beperkingsscore in het doelwit gewricht (100 mm-VAS)
    - Patiënt-gerapporteerde bewegingsbeperking score in het doelwit gewricht (100 mm-VAS)
    - Onderzoeker-vastgesteld Index Joint Score (gevoeligheid, zwelling, roodheid, warmte)
    - Onderzoeker-vastgesteld Globale Evaluatie van de ziekte (Likertschaal)
    - Bloedspiegels van hoge gevoeligheid C-reactief proteïne (hsCRP), Serum Amyloïd A eiwit (SAA) en inflammatoire cytokines
    - Mocht de proefpersoon zijn/haar pijn niet kunnen verdragen en graag de standaard medische behandeling ontvangen voor een jichtaanval, dan wordt deze proefpersonen uit de studie gehaald en gezien als een 'treatment failure'. De proefpersoon wordt dan behandeld met of prednisolon (30mg/dag) of colchicine (0.5mg, 3x daags). Naast de klinische activieit variabelen zoals hierboven beschreven wordt het aantal en percentage 'treatment failures' in elke cohort verzameld en samengevat in de studie resultaten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Subject-reported global evaluation of treatment (Likert scale): Day 7
    - Subject-reported pain intensity, general disability and walking disability score in the target joint (100 mm-VAS): Baseline (pre-dose), 2, 4, 6 and 12 hours post-dose, twice per day on Days 1 - 7, and Day 14
    - Investigator-assessed Index Joint Score & Investigator-assessed Global Rating of Disease (Likert scale): Baseline (pre- and post-dose), Day 3 and Day 7
    - Blood levels of high sensitivity C-reactive protein (hsCRP), Serum Amyloid A protein (SAA) and inflammatory cytokines: Baseline (pre-dose), Day 3, Day 7 and Day 14
    - Patient-gerapporteerde globale evaluatie van behandeling (Likertschaal): dag 7;
    - Patient-gerapporteerde pijn intensiteit, algemene beperkings- en bewegingsbeperkingsscore in het doelgewricht (100 mm VAS): baseline (pre-dosering, 2, 4, 6 en 12 uur post-dosering, tweemaal daags op dag 1 - 7 en dag 14.
    - Onderzoeker vastgestelde Index Joint Score en globale schatting van ziekte (Likertschaal): baseline (pre- en post-dosering), dag 3 en dag 7;
    - bloedspiegel van hoog gevoelig CRP (hsCRP), serum amyloide A eiwit (SAA) en inflammatoire cytokines: baseline (pre-dosering), dag 3, dag 7 en dag 14
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 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
    LVLS (telephone follow-up visit)
    LVLS (telefonische opvolg visite)
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 12
    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 state32
    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)
    After the subject has completed the study, he/she will return to the care of their referring physician for further evaluation and treatment of their gout.
    Nadat de patiënt de studie heeft afgerond, zal verdere zorg, evaluatie en behandeling voor jicht door de behandelend arts worden voortgezet.
    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 Decision2016-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-22
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    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.

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