Clinical Trials Register

Summary
EudraCT Number:	2011-003185-33
Sponsor's Protocol Code Number:	INRCA-02-2011
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-05
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-003185-33

A.3

Full title of the trial

Prospective, controlled, randomized, blind study to evaluate the effects of intramuscular-paravertebral injections of an oxygen-ozone (O2-O3) mixture in patients with lumbar pain aged 65 or older

Studio prospettico, controllato, randomizzato, in cieco, di valutazione degli effetti dell'ossigeno-ozono (O2-O3 per via intramuscolare paravertebrale) sul dolore lombare, in soggetti di eta' >= 65 anni

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Prospective, controlled, randomized, blind study to evaluate the effects of intramuscular-paravertebral injections of an oxygen-ozone (O2-O3) mixture in patients with lumbar pain aged 65 or older

Studio prospettico, controllato, randomizzato, in cieco, di valutazione degli effetti dell’ossigeno-ozono (O2-O3) per via intramuscolare paravertebrale sul dolore lombare, in soggetti di eta' >= 65 anni

A.3.2

Name or abbreviated title of the trial where available

O2-O3 Therapy

O2-O3 Terapia

A.4.1

Sponsor's protocol code number

INRCA-02-2011

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	ISTITUTO NAZIONALE DI RICOVERO E CURA PER ANZIANI IRCCS
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Istituto Nazionale di Ricovero e Cura per gli Anziani
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Regione Marche
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Istituto Nazionale di Ricovero e Cura per Anziani
B.5.2	Functional name of contact point	U.O. Riabilitazione Clinica
B.5.3	Address:
B.5.3.1	Street Address	via della Montagnola 81
B.5.3.2	Town/ city	Ancona
B.5.3.3	Post code	I-60131
B.5.3.4	Country	Italy
B.5.4	Telephone number	0718003276
B.5.5	Fax number	0718003503
B.5.6	E-mail	o.mercante@inrca.it

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	OSSIGENO*COMPR 200BAR 14L AC V
D.2.1.1.2	Name of the Marketing Authorisation holder	SOL SpA
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	Medicinal gas, compressed
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Other use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	7782-44-7
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Dioxygen
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	10028-15-6
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Triatomic oxygen
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	800
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	Yes
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	No

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

subjects aged 65 or older with lumbar pain and discopathy for at least 6 weeks

soggetti di età maggiore o uguale a 65 anni con dolore lombare associato a discopatia da almeno 6 settimane

E.1.1.1

Medical condition in easily understood language

subjects aged 65 or older with back pain and discopathy for at least 6 weeks

soggetti di età maggiore o uguale a 65 anni con mal di schiena associato a discopatia da almeno 6 settimane

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10028395
E.1.2	Term	Musculoskeletal and connective tissue disorders
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

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 evaluate the effects of intramuscolar-paravertebral injection of an oxygen-ozone mixture in the treatment of lumbar pain with discopathy

Valutazione degli effetti di iniezioni intramuscolari-paravertebrali di una miscela di ossigeno-ozono nel trattamento del dolore lombare associato a discopatia

E.2.2

Secondary objectives of the trial

1.comprehensive geriatric assessment 2.Paracetamol assumption 3. Determination of markers of oxidative stress and plasmatic trace elements (Zn, Cu, Fe, Se)

1. Valutazione Multidimensionale Geriatrica (VMD) 2. numero di dosi e numero di giorni di trattamento con paracetamolo 3. Identificazione di marcatori biologici di stress ossidativo e dosaggio microelementi nel plasma (Zn, Cu, Fe, Se)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. subjects aged 65 or older 2. lumbar pain and discopathy for at least 6 weeks 3.Patients with diagnostic imaging performed by no longer than two years to exclude the presence of diseases or morphological conditions listed in the exclusion criteria 4. Oswestry Disability Index between 30% and 80% 5. Patients free from steroidal and nonsteroidal antinflammatory drugs from at least 10 days

1. soggetti con età maggiore o uguale a 65 anni 2. presenza di dolore lombare,associato a discopatia, persistente da almeno 6 settimane 3. - pazienti che portino in visione indagini diagnostiche per immagini, effettuate da non più di due anni, che permettano di escludere la presenza di patologie o situazioni morfologiche elencate nei criteri di esclusione 4. Oswestry Disability Index compreso tra 30% e 80%. 5.Pazienti non trattati con farmaci antifiammatori steroidei e non steroidei da almeno 10 giorni

E.4

Principal exclusion criteria

1. clinical signs of radiculopathy 2. cauda equina syndrome 3. progressive neurologic deficit 4. lumbar stenosis 5. spondylolisthesis 6. lesions requiring immediately surgery 7. diabetic neuropathy 8. body mass index >30 9. lumbar scoliosis >20° 10. favism 11. Known or suspected hypersensitivity to paracetamol or controindications of its use

1. segni clinici di radicolopatia 2. sindrome della cauda equina 3. deficit neurologico progressivo 4. stenosi lombare 5. spodilolistesi 6. lesioni che richiedono un immediato intervento chirurgico 7. neuropatia diabetica 8. body mass index >30 9. scoliosi lombare > di 20° 10. favismo 11. Nota o sospetta ipersensibilità al paracetamolo o controindicazioni al suo uso

E.5 End points

E.5.1

Primary end point(s)

Changes in Disability Index (ODI) obtained after administration dell'Oswestry Disability Questionnaire. Response to treatment is a binary classification: ''success'' if the Oswestry Disability Index at follow-up is between 0 and 20% and ''failure'' in the other cases.

Variazioni dell’Indice di Disabilità (ODI) ricavato dalla somministrazione dell’Oswestry Disability Questionnaire. La risposta al trattamento è considerata binaria e classifica come “successo” se l’Oswestry Disability Index al follow-up è compreso tra 0 e 20% ed “insuccesso” negli altri casi.

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 1: baseline; Visit 2: 2 weeks of treatment; Visit 3: 4 weeks of treatment; Visit 4: 6 weeks of treatment; Visit 5: 2 weeks of follow-up; Visit 6: 3 months of follow-up; Visit 7: 6 months of follow-up

Visita 1: baseline; Visita 2: 2 settimane di trattamento; Visita 3: 4 settimane di trattamento; Visita 4: 6 settimane di trattamento; Visita 5: 2 settimane di follow-up; Visita 6: 3 mesi di follow-up; Visita 7: 6 mesi di follow-up

E.5.2

Secondary end point(s)

Comprehensive geriatric assessment by INTERRAI-HC/VAOR-ADI instrument.

Valutazione multidimensionale geriatrica attraverso lo strumento INTERRAI-HC/VAOR-ADI

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit 1: baseline; visit 6: 3 months of follow-up; visit 7: 6 months of follow-up

Visita 1: baseline; visita 6: 3 mesi di follow-up; visita 7: 6 mesi di follow-up

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

iniezione simulata paravertebrale lombare

simulated lumbar paravertebral injection

E.8.2.4

Number of treatment arms in the trial

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

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

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

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

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

130

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

130

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)

The study takes into account a treatment that also includes the administration of a single cycle. The study design includes a treatment cycle followed by a follow-up period of 6 months, which seems appropriate for the type of treatment. At the end of the study period, the patients will continue to be treated at the trial site by conventional therapy

Lo studio prende in considerazione un trattamento che prevede anche la sola somministrazione di un unico ciclo. Il disegno dello studio include un ciclo di trattamento seguito da un periodo di follow up della durata di 6 mesi, che appare congruo per la tipologia del trattamento stesso. Al completamento del periodo di studio il paziente potrà continuare ad essere seguito nel centro di sperimentazione e trattato in modo convenzionale

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

2011-10-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-13

P. End of Trial
P.	End of Trial Status	Ongoing

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