임상 시험 Nct 페이지

Summary
EudraCT Number:2004-002249-11
Sponsor's Protocol Code Number:BLQ-01-003-04
National Competent Authority:Italy - Italian Medicines Agency
Clinical Trial Type:EEA CTA
Trial Status:Prematurely Ended
Date on which this record was first entered in the EudraCT database:2004-10-05
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
A. Protocol Information
A.1Member State ConcernedItaly - Italian Medicines Agency
A.2EudraCT number2004-002249-11
A.3Full title of the trial
Double blind, randomized, multicenter, placebo-controlled, parallel-group design clinical trial of the efficacy and tolerability of cloriclomene hydrochloride capsules 100 mg TID in diabetic patients with mild to moderate non-proliferative retinopathy
Studio in doppio cieco, randomizzato, multicentrico, controllato verso placebo a gruppi paralleli sull`efficacia e la tollerabilita` di Cloricromene capsule da 100 mg, somministrato tre volte al giorno, in pazienti diabetici con retinopatia non proliferante di grado lieve o moderato
A.4.1Sponsor's protocol code numberBLQ-01-003-04
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 SponsorBAUSCH&LOMB - IOM S.P.A.
B.1.3.4CountryItaly
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 Yes
D.2.1.1.1Trade name PROENDOTEL*30CPS 100MG
D.2.1.2Country which granted the Marketing AuthorisationItaly
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 Gastro-resistant 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.3.9.1CAS number 68206-94-0
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
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 Yes
D.3.11.13.1Other medicinal product typeNon Applicabile
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
Mild to moderate non-proliferative diabetic retinopathy
Prevenzione della progressione della retinopatia non proliferante diabetica di grado lieve o moderato
E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
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 demonstrate that the oral therapy with Proendotel 100 mg three times/per day given for 24 months, is superior to placebo in the arrest of progression of non-proliferative retinopathy in patients with diabetes of type I and II (insulin or non-insulin dependent)
Dimostrare che la terapia Proendotel 100 mg tre volte al giorno per via orale somministrata per 24 mesi e' superiore al placebo nell'arrestare la progressione della retinopatia non proliferante in pazienti diabetici di tipo I e II (insulino-dipendenti e non insulino-dipedenti)
E.2.2Secondary objectives of the trial
to evaluate the effects of Cloricromene hydrochloride on visual acuity and to evaluate the effects of Cloricromene hydrochloride on changes of macular edema (presence and severity) and retinal thickness; to evaluate the safety and tolerability profile of Cloricromene hydrochloride.
- valutare gli effetti del cloricromene cloridrato sull'acuita' visiva e sull'inibizione dell'edema maculare clinicamente significativo- valutare la tollerabilita' del cloricromene cloridrato
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Written informed consent obtained. Male or female patients aged > = 18 years and < = 75 years; Clinical diagnosis of insulin dependent diabetes mellitus (IDDM, type 1) or non-insulin dependent diabetes mellitus (NIDDM, type 2) treated with insulin or oral anti-hypoglycemic drugs; Mild (level 35) or moderate (level 43 A-B and 47 A-D) non-proliferative diabetic retinopathy (38) in at least one eye, as determined by using ETDRS standard fields 30-degree Stereoscopic Color Fundus Photography; Glycosylated hemoglobin (HbA1c) levels < 10% and Patients with IDDM able to self-measure their blood glucose levels at home and to adjust their insulin dosage to maintain blood glucose control; A Best Corrected Visual Acuity score of 75 or more (20/32 or better) as measured by using ETDRS visual protocol (39) Absence of macular edema or presence of non-clinically significant diabetic macular edema; Media clarity, papillary dilation and patient cooperation sufficient to allow stereoscopic cooperation sufficient to allow stereoscopic 30? fundus photographs of adequate quality in at least one eye that meets the above criterion on visual acuity; Blood pressure controlled (DBP < 100 mmHg and SBP < 160 mmHg with or without medication);
Firma del consenso informato Donne e Uomini tra i 18 e 75 anni Pazienti affetti da Diabete Mellito Insulino-dipendenti e Diabete Mellito non Insulino-dipendenti (tipo I e II) Pazienti affetti da retinopatia non proliferativa lieve (livello 35) o moderata (livello 43 A-B e 47 A-D) in almeno uno dei due occhi determinata utilizzando l ETDRS 7 e la fotografia stereoscopica del fundus HbA1c&lt;10% al momento dell entrata del paziente nello studio. Inoltre, i pazienti diabetici insulino-dipendenti devono essere in grado di misurare autonomamente i livelli di glucosio nel sangue a casa e di aggiustare il dosaggio dell insulina al fine di mantenere tali livelli di glucosio sotto controllo. Acuita` visiva (20/32 o migliore) misurata utilizzando l ETDRS Assenza di edema maculare o presenza di edema maculare dovuto al diabete non clinicamente significativo. Mezzi diottrici trasparenti e buona midriasi pupillare. Paziente cooperante a effettuare la fotografia del fundus (che sia qualitativamente accettabile) in almeno un occhio che soddisfi i criteri relativi all acuita` visiva sopracitati Pazienti con una pressione sanguigna arteriosa controllata al momento dell ingresso nello studio (DBP &lt; 100 mmHg e SBP &lt; 160mmHg sia sotto controllo farmacologico che non)
E.4Principal exclusion criteria
History of photocoagulation for diabetic macular edema in the study eye except focal photocoagulation at least 6 months before. History of any pan retinal photocoagulation for diabetic macular edema in the study eye; Presence of clinically significant diabetic macular edema Current vitreous or preretinal hemorrhage; Concomitant treatment with hemorrheological, vasoactive drugs and antithrombotics except acetylsalicylic acid; History of hypersensitivity to fluorescin; Patients with clinical history of diathesis and hemorrhage disease; Pregnant or lactating females or females at risk of pregnancy contraception.i.e. those intending to become pregnant or those not demonstrating adequate contraception. Patients who received any investigational new drug within the last 12 months; Surgery or trauma within the past 12 months; Planned surgical intervention within 12 months from enrolment.
Storia di fotocoagulazione per edema maculare, dovuto al diabete, nell occhio in studio eccetto pazienti che hanno effettuato una fotocoagulazione focale nei sei mesi precedenti l ingresso nello studio. Storia di fotocoagulazione panretinica per edema maculare dovuto al diabete nell occhio in studio. Presenza di edema maculare clinicamente significativo, dovuto al diabete. Emorragia preretinica o vitrea in corso. Trattamenti concomitanti con farmaci anticoagulanti o antiaggreganti piastrinici e antitrombotici, eccetto l acido acetilsalicilico. Storia di ipersensibilita` alla fluoresceina. Pazienti con storia clinica di Diatesi e malattie emorragiche Ipersensibilita` al farmaco in studio Donne in gravidanza e allattamento oppure donne che hanno intenzione di avere una gravidanza nel periodo di tempo di durata dello studio Partecipazione ad un trial negli ultimi 12 mesi Operazione chirurgica o trauma negli ultimi 12 mesi Operazione chirurgica programmata nei dodici mesi successivi l arruolamento del paziente nello studi
E.5 End points
E.5.1Primary end point(s)
To demonstrate that the treatment with Cloricromene hydrochloride is superior to placebo in the arrest of progression of non-proliferative retinopathy, observed with the Fundus Oculi photograph and with Fluorangiography
Dimostrare che il trattamento con cloricromene cloridrato e' superiore al placebo nell'arrestare la progressione della retinopatia, osservata conla fotografia del Fundus Oculi e con la Fluorangiografia
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 No
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
B
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
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 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.8.2.4Number 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 concerned15
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 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
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 months
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.1.1Number of subjects for this age range: 0
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.1.3Elderly (>=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 Yes
F.3.3.1Women of childbearing potential not using contraception Yes
F.3.3.2Women of child-bearing potential using contraception No
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 state300
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 Decision2004-09-20
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-09-20
P. End of Trial
P.End of Trial StatusPrematurely Ended

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