Clinical Trials Register

Summary
EudraCT Number:	2006-003482-14
Sponsor's Protocol Code Number:	KF5503/24-R331333-PAI-3007
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-15
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

Spain - AEMPS

A.2

EudraCT number

2006-003482-14

A.3

Full title of the trial

A One-Year, Randomized, Open-Label, Parallel-Arm, Phase III Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR* and Oxycodone CR in Subjects with Chronic Pain

Estudio en Fase III de seguridad a largo plazo, aleatorizado, abierto, en grupos paralelos, con ajuste controlado de dosis, de un año de seguimiento sobre dosis múltiples de CG5503 LP* y Oxicodona LC en pacientes con dolor crónico.

A.3.1

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

A One-Year, Randomized, Open-Label, Parallel-Arm, Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 Prolonged release and Oxycodone Controlled Release in Subjects with Chronic Pain

A.4.1

Sponsor's protocol code number

KF5503/24-R331333-PAI-3007

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	Laboratorios Andrómaco, S.A.
B.1.3.4	Country	Spain
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	Laboratorios Andromaco S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Laboratorios Andromaco S.A.
B.5.2	Functional name of contact point	Gerente de Registros
B.5.3	Address:
B.5.3.1	Street Address	Doctor Zamenhof 36
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28027
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34913019300
B.5.5	Fax number	+34913019304
B.5.6	E-mail	regulatory.es@grunenthal.com

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	No
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.3.1	Product name	CG5503; R331333
D.3.2	Product code	CG5503; R331333
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Tapentadol
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	No
D.IMP: 2
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	No
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.3.1	Product name	CG5503; R331333
D.3.2	Product code	CG5503; R331333
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Tapentadol
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
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	No
D.IMP: 3
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	No
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.3.1	Product name	CG5503; R331333
D.3.2	Product code	CG5503; R331333
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Tapentadol
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	No
D.IMP: 4
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	No
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.3.1	Product name	CG5503; R331333
D.3.2	Product code	CG5503; R331333
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Tapentadol
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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	No
D.IMP: 5
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	No
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.3.1	Product name	CG5503; R331333
D.3.2	Product code	CG5503; R331333
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Tapentadol
D.3.9.1	CAS number	175591-09-0
D.3.9.3	Other descriptive name	(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
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	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Comparator
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	OxyContin® recubierto, comprimidos de liberación prolongada
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmceuticals Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.1	Product name	OxyContin®
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Oxycodone
D.3.9.2	Current sponsor code	n. a.
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	No
D.IMP: 7
D.1.2 and D.1.3	IMP Role	Comparator
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	OxyContin® recubierto, comprimidos de liberación prolongada
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmceuticals Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.1	Product name	OxyContin®
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Oxycodone
D.3.9.2	Current sponsor code	n. a.
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	No
D.IMP: 8
D.1.2 and D.1.3	IMP Role	Comparator
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	OxyContin® recubierto, comprimidos de liberación prolongada
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmceuticals Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.1	Product name	OxyContin®
D.3.4	Pharmaceutical form	Prolonged-release tablet
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.3.8	INN - Proposed INN	Oxycodone
D.3.9.2	Current sponsor code	n. a.
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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	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

Chronic pain due to knee or hip osteoarthritis or low back pain

Dolor crónico debido a artrosis de rodilla o cadera o lumbalgia

E.1.1.1

Medical condition in easily understood language

Chronic pain due to knee or hip osteoarthritis or low back pain

E.1.1.2

Therapeutic area

Body processes [G] - Biological Phenomena [G16]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10049475
E.1.2	Term	Chronic pain
E.1.2	System Organ Class	10018065 - General disorders and administration site conditions

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the trial will be evaluation of the safety profile of CG5503 PR base at doses 100 mg - 250 mg BID over long-term exposure of up to one year

El objetivo principal del presente ensayo clínico es la evaluación del perfil de seguridad de CG5503 LP en dosis (base) de 100 mg a 250 mg dos veces al día tras una exposición a largo plazo de hasta un año de duración.

E.2.2

Secondary objectives of the trial

Assessment of CG5503 PR and oxycodone CR dose requirements during long-term exposure.
Evaluation of symptoms related to constipation using the Patient?s Assessment of Constipation Symptoms (PAC-SYM).
Evaluate sleep quality by using Sleep Questionnaire (SQ).
Evaluation for symptoms of withdrawal following discontinuation of treatment using both the Clinical Opiate Withdrawal Scale (COWS) and, in the US, the Subjective Opiate Withdrawal Scale (SOWS) questionnaires.
Assessment of efficacy over the one-year trial period, based on pain intensity scores using an 11-point Numerical Rating Scale (NRS).
Assessment of efficacy based on the subject?s and Investigator?s global assessment of the IMP.
Assessment of efficacy based on Patient?s Global Impression of Change (PGIC) using a 7-point verbal rating scale.
Assessment of quality of life based on EuroQol-5 Dimension (EQ-5D).
Assessment of quality of life based on Short Form-36 Health Survey (SF-36®).

?Requerimientos de CG5503 LP y de oxicodona durante la exposición a largo plazo
?Síntomas relacionados con el estreñimiento (Cuestionario de Valoración de los Síntomas de Estreñimiento por parte del Paciente (PAC-SYM).)
?Calidad del sueño (Cuestionario del Sueño (CS)).
?Síntomas de retirada tras la interrupción del tratamiento (Escala Clínica de Dependencia tras la Retirada de Opioides (COWS) y Escala Subjetiva de Dependencia tras la Retirada de Opioides (SOWS)).
?Eficacia durante el periodo de seguimiento de un año mediante una Escala Numérica de Puntuación de 11 puntos (NRS).
?Eficacia en función de la valoración global del PME por el paciente y el investigador.
?Eficacia mediante la Escala de Impresión Global de Cambio por el Paciente (IGCP) mediante una escala verbal de 7 categorías.
?Calidad de vida (EuroQol-5 Dimensiones (EQ-5D)).
?Calidad de vida (SF-36 (SF-36®)).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Pacientes varones o mujeres no embarazadas ni en periodo de lactancia. Las mujeres que mantengan una vida sexual activa deben ser bien posmenopáusicas, bien estériles quirúrgicamente, bien seguir un método anticonceptivo eficaz (tal como anticonceptivos orales bajo control médico, inyecciones anticonceptivas, dispositivos intrauterinos, procedimientos de doble barrera, esterilización del miembro masculino de la pareja) antes y durante el estudio. En el momento de la selección todas las mujeres deberán presentar una prueba de embarazo basada en ß-hCG en suero negativa.
2. Pacientes con edades iguales o superiores a 18 años.
3. Pacientes que no estén satisfechos con su tratamiento analgésico actual (como AINEs, iCOX-2, opioides, paracetamol).
4. Pacientes que presenten una intensidad de dolor >4 en la NRS en el momento basal tras el periodo de lavado.
5. Pacientes con un diagnóstico clínico de artrosis de rodilla o cadera con antecedentes de dolor en la articulación de referencia al menos durante los últimos 3 meses o con diagnóstico clínico de lumbalgia no maligna con al menos 3 meses de evolución.
6. Pacientes que otorguen su consentimiento informado que atestigüe su correcta comprensión de los propósitos y los procedimientos del estudio y que desean participar voluntariamente en el mismo.

E.4

Principal exclusion criteria

Generales:
1. Pacientes que estén participando en otro ensayo clínico de forma simultánea o durante los 30 días anteriores a la entrada en el estudio de CG5503.
2. Pacientes que hayan participado previamente en este o en otros estudios de CG 5503.
3. Pacientes con antecedentes de abuso de alcohol o drogas según el criterio del investigador, la historia clínica o la exploración física.
4. Pacientes con incapacidad, conocida o sospechada, para cumplir el protocolo del estudio o utilizar la medicación del estudio.
5. Pacientes con cirugía mayor programada o probable durante el periodo del estudio.
6. Pacientes sometidos a intervenciones quirúrgicas en la articulación de referencia o en la columna lumbar en los 3 meses anteriores a la visita de selección.
7. Pacientes con alguna relación laboral con el investigador o con el centro del estudio, que tengan relación directa con el presente estudio o con otros estudios que el investigador o el centro haya o esté llevando a cabo en la actualidad, o que sean parientes de personas con alguna relación laboral con el investigador.
8. Pacientes que padezcan alguna enfermedad clínicamente relevante que, en opinión del investigador, pueda interferir con las evaluaciones de eficacia o de seguridad del estudio.

Específicos del estudio:
1. Antecedentes de trastornos convulsivos o epilepsia en cualquier momento de la vida; de lesiones cerebrales traumáticas leves/moderadas, ictus, accidente isquémico transitorio, o neoplasia cerebral en el último año; de lesiones cerebrales traumáticas severas en los 15 años anteriores (con uno o más de los siguientes criterios: contusión cerebral, hematoma intracraneal, pérdida de conciencia o amnesia postraumáticas durante más de 24 horas) o que presenten secuelas residuales que sugieran cambios transitorios del estado de conciencia.
2. Pacientes con antecedentes de enfermedad maligna en los 2 años anteriores, a excepción de carcinoma basocelular tratado satisfactoriamente.
3. Pacientes con hipertensión no controlada (presión arterial sistólica >160 mm Hg o presión arterial diastólica >95 mm Hg).
4. Pacientes en tratamiento con medicaciones prohibidas (véase el apartado correspondiente a la medicación concomitante).
5. Pacientes con resultados analíticos que sugieran función hepática inadecuada (ALT y/o AST por encima de 3 veces el límite superior de la normalidad).
6. Pacientes con insuficiencia renal moderada o severa, según los criterios de definición que se utilicen en el país correspondiente.
7. Pacientes con antecedentes de hipersensibilidad o alergia a oxicodona o paracetamol, o con contraindicación para estos fármacos.
8. Pacientes que estén en litigio por incapacidad en la actualidad o lo hayan estado en el pasado.
9. Pacientes con dolor importante causado por otros procesos diferentes a la artrosis o la lumbalgia que pudiese confundir las evaluaciones del dolor.

E.5 End points

E.5.1

Primary end point(s)

No formal statistical testing will be performed in this study.

En el presente estudio no se realizarán contrastes estadísticos formales.

E.5.1.1

Timepoint(s) of evaluation of this end point

Not applicable

No aplica

E.5.2

Secondary end point(s)

not applicable

No aplica

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

no Aplica

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

Yes

E.6.7

Pharmacodynamic

Yes

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

Yes

E.8.1.3

Single blind

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)

Yes

E.8.2.2

Placebo

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Belgium

Croatia

Czech Republic

France

Germany

Ireland

Netherlands

Portugal

Slovakia

Slovenia

Spain

United Kingdom

United States

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

Last visit for the last patient

última visita del último paciente

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero