Clinical Trials Register

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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2004-002249-11

A.3

Full 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.4.1

Sponsor's protocol code number

BLQ-01-003-04

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	BAUSCH&LOMB - IOM S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PROENDOTEL*30CPS 100MG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	68206-94-0
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical 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.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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<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 < 100 mmHg e SBP < 160mmHg sia sotto controllo farmacologico che non)

E.4

Principal 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.5.1

Primary 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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	Yes
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	300

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2004-09-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2004-09-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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