Clinical Trials Register

Summary
EudraCT Number:	2008-002670-36
Sponsor's Protocol Code Number:	OXN3503
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:	2008-12-18
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

2008-002670-36

A.3

Full title of the trial

A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate non-inferiority in pain and locomotor function and improvement in symptoms of constipation in subjects with moderate to severe pain due to osteoarthritis (OA) of the knee and/or hip taking oxycodone equivalent of 20 - 80 mg/day as oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking oxycodone prolonged release tablets (OxyPR) alone.

Estudio multicéntrico aleatorizado, doble ciego, doble simulación, de grupos paralelos, para demostrar no inferioridad con respecto al dolor y la función locomotriz, así como la mejoría de los síntomas de estreñimiento, en sujetos con dolor de moderado a intenso debido a una artrosis de rodilla y/o de cadera que tomen equivalentes de oxicodona de 20-80 mg/día como comprimidos de oxicodona/naloxona de liberación prolongada (OXN PR) en comparación con sujetos que tomen únicamente comprimidos de oxicodona de liberación prolongada (OxyPR).

A.4.1

Sponsor's protocol code number

OXN3503

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Mundipharma Research GmbH & Co. KG
B.1.3.4	Country	Germany
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	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	oxycodone/naloxone prolonged release tablets 5/2.5 mg
D.3.2	Product code	OXN PR 5/2.5 mg
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	naloxone hydrochloride
D.3.9.1	CAS number	357-08-4
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	2.5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.2.1.1.1	Trade name	Targin® 10/5 mg prolonged-release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Mundipharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Naloxone hydrochloride
D.3.9.1	CAS number	357-08-4
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	5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Yes
D.2.1.1.1	Trade name	Targin® 20/10 mg prolonged-release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Mundipharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Naloxone hydrochloride
D.3.9.1	CAS number	357-08-4
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	oxycodone/naloxone prolonged release tablets 40/20 mg
D.3.2	Product code	OXN PR 40/20 mg
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Naloxone hydrochloride
D.3.9.1	CAS number	357-08-4
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	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® 5 mg film-coated, prolonged release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmaceuticals 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.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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	5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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® 10 mg film-coated, prolonged release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmaceuticals 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.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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® 20 mg film-coated, prolonged release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmaceuticals 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.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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® 40 mg film-coated, prolonged release tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Napp Pharmaceuticals 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.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 hydrochloride
D.3.9.1	CAS number	124-90-3
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 5
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 6
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 7
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 8
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Prolonged-release tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pain, locomotor function and improvement in constipation in osteoarthritis patients taking opioids

Dolor, artrosis y mejoramiento en el extreñimiento en pacientes con osteoporosis que estan tomando opioides.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10031161
E.1.2	Term	Osteoarthritis

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10021175
E.1.2	Term	Iatrogenic constipation

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

? demostrar que el tratamiento con los comprimidos de OXN PR es no inferior al tratamiento con OxyPR con respecto a la eficacia analgésica y la función locomotriz evaluadas según el Western Ontario and McMaster Universities Osteoarthritis Composite Index (WOMAC VA3.1, escala analógica visual) en sujetos con dolor de moderado a intenso por artrosis.
? demostrar que los sujetos con dolor artrósico de moderado a intenso que toman comprimidos de liberación prolongada de oxicodona/naloxona experimentan una mejoría de los síntomas de estreñimiento, medida mediante el Indice de Función Intestinal (IFI), en comparación con los sujetos que tomen únicamente comprimidos de liberación prolongada de oxicodona.

E.2.2

Secondary objectives of the trial

? estimar el dolor medio de los sujetos en las últimas 24 horas, evaluado en cada visita de doble enmascaramiento del estudio durante el tratamiento con OXN PR en comparación con OxyPR.
? evaluar la valoración que haga el sujeto del estreñimiento inducido por el opioide, la intensidad de los síntomas de estreñimiento y el efecto y las molestias según la PAC-SYM (b).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Varón o mujer de al menos 18 años de edad
2. Las mujeres que tengan la menopausia hace menos de un año tendrán que tener registrada una prueba de embarazo negativa antes de la primera dosis de la medicación del estudio, no deberán estar en periodo de lactancia y deberán estar dispuestas a utilizar métodos anticonceptivos apropiados y muy eficaces durante todo el estudio. Se definen como métodos de control de la natalidad muy eficaces los que provocan bajas tasas de fracaso (es decir, menos del 1% al año) cuando se utilizan de manera constante y correcta, como la esterilización, los implantes, los inyectables, los anticonceptivos orales combinados, algunos DIU (dispositivo intrauterino, hormonales), la abstinencia sexual o la vasectomía de la pareja.
3. Artrosis de origen no neoplásico crónica de moderada a intensa, cuyo principal foco de dolor es la(s) cadera(s) y/o la(s) rodilla(s) y que necesita tratamiento con opiáceos durante las 24 horas del día (equivalente de oxicodona de 20-80 mg/día).
4. Sujetos que necesiten continuar el tratamiento diario con opioides y que sea probable que vayan a beneficiarse del tratamiento con opioides del escalón III de la escalera analgésica de la OMS mientras dure el estudio.
5. Sujetos con diagnóstico clínico de artrosis degenerativa o primaria, respaldada por una de las siguientes pruebas: una resonancia magnética (RM), una tomografía axial computarizada (TAC), una artroscopia o una radiografía. Las imágenes clínicas de artrosis pueden incluir una o más de las siguientes características: estrechamiento del espacio articular, cambios degenerativos, formación de osteofitos o quistes subcondrales. Los sujetos identificarán la articulación más dolorosa (cadera o rodilla) para documentación de la artrosis. La determinación del dolor se realizará sólo en esta articulación.
6. Sujetos que estén recibiendo tratamiento analgésico del escalón II o III de la escalera analgésica de la OMS y en los que, en opinión del sujeto y confirmado por el investigador, el tratamiento con opioides previo al estudio (presente en la fase de selección) induce estreñimiento o lo empeora.
7. Sujetos que puedan y estén dispuestos a participar en todos los aspectos del estudio principal (empleo de medicación por vía oral, completar las evaluaciones subjetivas, presentarse a las visitas programadas a la clínica, completar los contactos telefónicos y cumplir los requisitos del protocolo), lo cual quedará demostrado mediante la entrega del consentimiento informado por escrito, y que estén dispuestos a interrumpir su rutina analgésica con opioides actual, su régimen con laxantes y a tomar bisacodilo oral como tratamiento laxante de rescate.
8. Los sujetos que tomen a diario un complemento de fibras o agentes formadores de masa son idóneos si pueden mantenerse con una dosis y un régimen estables durante todo el estudio y, si en opinión del investigador, están dispuestos a mantener una hidratación adecuada y son capaces de ello.
9. Son idóneos los sujetos que estén tomando analgésicos no opioides antes del estudio, y todos los demás tratamientos concomitantes, entre ellos medicación para el tratamiento de la depresión, así como tratamiento no médico, que se consideren estables y necesarios para el bienestar del sujeto, y que se prevea que van a mantenerse estables durante todo el periodo de doble enmascaramiento del estudio y que vayan a seguir bajo la supervisión del investigador.

Criterios para entrar en fase de doble enmascaramiento:
1. Los sujetos siguen cumpliendo los criterios de inclusión y exclusión de la fase de selección.
2. La dosis de OxyPR que esté tomando el sujeto debe estar comprendida entre 20 y 80 mg/día.
3. Los sujetos deben calificar su dolor ("dolor medio" a lo largo de las últimas 24 horas) como ? 4 en una escala de 0 a 10 con dos dosis o menos de oxicodona de liberación inmediata (OxyIR) como medicación de rescate al día (Tabla 1 del protocolo) o bien durante los tres últimos días consecutivos o bien durante cuatro de los últimos siete días antes de la aleatorización.
4. Los sujetos deben tener estreñimiento relacionado con los opioides confirmado, que se define como menos de 3 evacuaciones espontáneas completas, sin esfuerzos (CSBM-NS, de sus siglas en inglés) durante los 7 últimos días antes de la aleatorización. El número máximo permitido de tomas de bisacodilo es de cinco administraciones de 10 mg/día de bisacodilo. A discreción del investigador, la dosis de bisacodilo puede reducirse en los 7 últimos días del periodo de preinclusión.
5. Los sujetos demuestran cumplimiento del uso del laxante y de la OxyPR sin enmascarar, y completan todos los días sus diarios.

E.4

Principal exclusion criteria

1. Mujeres que estén embarazadas (prueba ?-hCG positiva) o en período de lactancia.
2. Sujetos con cualquier contraindicación o antecedentes de hipersensibilidad al bisacodilo, la oxicodona, la naloxona, productos relacionados u otros compuestos.
3. Sujetos con artrosis secundaria (por ejemplo, fractura, septicemia, acromegalia).
4. Sujetos con sustitución de la articulación más dolorosa ( rodilla o cadera).
5. Sujetos con signos de anomalías estructurales significativas del tubo digestivo (por ejemplo, obstrucción intestinal, estenosis) o cualquier enfermedad o dolencia que afecte al tránsito intestinal (por ejemplo, íleo, hipotiroidismo).
6. Sujetos que precisen tratamiento para el diagnóstico de síndrome de intestino irritable (SII); cirugía en los dos meses previos al comienzo del período de selección o cirugía prevista durante las 12 semanas de la fase de doble enmascaramiento que pueda afectar a la motilidad gastrointestinal o al dolor.
7. Sujetos con dolor asociado a cáncer.
8. Sujetos con enfermedad crónica de las articulaciones de naturaleza recidivante/remitente o cualquier otra dolencia crónica que provoque un dolor que justifique probablemente el uso persistente de analgésicos de rescate (por ejemplo, gota, artritis reumatoide (AR)).
9. Pruebas de enfermedad cardiovascular, renal, hepática o psiquiátrica clínicamente significativa, determinada mediante anamnesis, análisis clínicos, resultados del ECG y exploración física, que pondrían al sujeto en riesgo tras la exposición a la medicación del estudio o que pueden confundir el análisis o la interpretación de los resultados del estudio.
10. Sujetos con signos de deterioro de la función hepática o renal tras su entrada en el estudio, definido como niveles de aspartato aminotransferasa (AST; SGOT), alanina aminotransferasa (ALT; SGPT) o fosfatasa alcalina > tres veces el límite superior normal; gammaglutamiltranspeptidasa (GGT o GGTP) ? 5 veces el límite superior normal; nivel de bilirrubina total fuera del intervalo de referencia; o nivel de creatinina fuera del intervalo de referencia o, en opinión del investigador, un deterioro hepático o renal de tal extensión que el sujeto no debe participar en este estudio.
11. Sujetos que estén tomando en la actualidad o que hayan tomado naloxona o naltrexona en los 30 días previos a la entrada en el estudio (definida como el comienzo del periodo de selección).
12. Sujetos que estén recibiendo hipnóticos u otros depresores del sistema nervioso central (SNC) que, en opinión del investigador, puedan plantear un riesgo de depresión añadida del sistema nervioso central con los opioides del tratamiento en estudio.
13. Sujetos que reciban tratamiento de sustitución de opioides por adicción a los opioides (por ejemplo, metadona o buprenorfina)
14. Sujetos con adicción al alcohol o las drogas o antecedentes de adicción a opiáceos.
15. Sujetos que hayan recibido una nueva entidad química o un fármaco experimental en los 30 días previos a la entrada en el estudio (definida como el comienzo del periodo de selección).
16. Sujetos en cualquier situación en la que estén contraindicados los opioides, depresión respiratoria grave con hipoxia o hipercapnia, enfermedad pulmonar obstructiva crónica grave, cor pulmonar, asma bronquial intensa, íleo paralítico.
17. Sujetos con mixoedema, hipotiroidismo, enfermedad de Addison, aumento de la presión intracraneal o epilepsia.

E.5 End points

E.5.1

Primary end point(s)

? Evaluación del dolor y de la función locomotriz del sujeto mediante el Western Ontario and McMaster Universities Osteoarthritis Composite Index (WOMAC VA3.1, escala analógica visual).
? El Indice de Función Intestinal (IFI) será la media de los siguientes aspectos (evaluados en cada visita durante los siete últimos días): facilidad de defecación (escala analógica numérica [EAN], 0 = fácil/no difícil; 100 = dificultad intensa); sensación de evacuación intestinal incompleta (EAN, 0 = nada en absoluto, 100 = muy intensa); juicio personal de estreñimiento (EAN, 0 = nada en absoluto, 100 = muy intenso).

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

overall health

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.7.1

Other trial design description

double-dummy

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.8.3

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

100

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

Information not present in EudraCT

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

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
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	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
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	16
F.4.2	For a multinational trial
F.4.2.1	In the EEA	180
F.4.2.2	In the whole clinical trial	200

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

2009-01-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-01-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-07-09

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