Clinical Trials Register

Summary
EudraCT Number:	2009-010719-33
Sponsor's Protocol Code Number:	Gebro-III-48-4
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-04-30
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

Austria - BASG

A.2

EudraCT number

2009-010719-33

A.3

Full title of the trial

Prospective, clinical trial to investigate safety, tolerability and efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension (test) compared to Ibuprofen 400 mg powder for oral suspension (reference) in patients suffering from osteoarthritis of the hip or knee

A.3.1

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

Investigaton of Safety, Tolerability of two preparations in patients suffering from osteoarthritis of the hip or knee

A.3.2

Name or abbreviated title of the trial where available

Dexibuprofen powder for oral suspension

A.4.1

Sponsor's protocol code number

Gebro-III-48-4

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	Gebro Pharma GmbH
B.1.3.4	Country	Austria
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	Gebro Pharma GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gebro Pharma GmbH
B.5.2	Functional name of contact point	Dr. Norbert Eller
B.5.3	Address:
B.5.3.1	Street Address	Bahnhofbichl 13
B.5.3.2	Town/ city	Fieberbrunn
B.5.3.3	Post code	6391
B.5.3.4	Country	Austria
B.5.4	Telephone number	0043/5354/5300
B.5.5	Fax number	0043/5354/5300-743
B.5.6	E-mail	norbert.eller@gebro.com

D. IMP Identification
D.IMP: 1
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	Spidifen
D.2.1.1.2	Name of the Marketing Authorisation holder	Zambon
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.3.1	Product name	Ibuprofen powder for oral suspension
D.3.4	Pharmaceutical form	Powder for oral suspension
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	Ibuprofen
D.3.9.1	CAS number	57469-77-9
D.3.9.2	Current sponsor code	Ibuprofen
D.3.9.3	Other descriptive name	IBUPROFEN ARGININE
D.3.9.4	EV Substance Code	SUB22225
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	400
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	Yes
D.2.1.1.1	Trade name	Dexibuprofen Sachet
D.2.1.1.2	Name of the Marketing Authorisation holder	Gebro Pharma GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	Dexibuprofen powder for oral suspension
D.3.4	Pharmaceutical form	Powder for oral suspension
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	DEXIBUPROFEN
D.3.9.1	CAS number	51146-56-6
D.3.9.2	Current sponsor code	Dexibuprofen
D.3.9.3	Other descriptive name	Dexibuprofen
D.3.9.4	EV Substance Code	SUB07030MIG
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	400
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	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	Spididol 400mg Granulato per soluzione orale
D.2.1.1.2	Name of the Marketing Authorisation holder	Zambon Italia s.r.l., via Lillo del Duca, 20091 Bresso
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	Powder for oral suspension
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	Ibuprofen
D.3.9.1	CAS number	57469-77-9
D.3.9.2	Current sponsor code	Ibuprofen
D.3.9.3	Other descriptive name	IBUPROFEN ARGININE
D.3.9.4	EV Substance Code	SUB22225
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	400
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

Osteoarthritis of the hip or knee

E.1.1.1

Medical condition in easily understood language

Osteoarthritis of the hip or knee

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

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 evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee

E.2.2

Secondary objectives of the trial

To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

male or female patients; age between 18 and 85 years; informed consent of the patient; everyday joint pain for the past three months; global pain intensity in the involved joint (hip or knee) of “moderate” to “severe” within the last 48 h [on the Likertscale: mild, moderate, severe, extreme]: mild: no impairment of the quality of life, no disorder of night pain, pain at different functions less than 1 hourmoderate: recognizable impairment of the quality of life, pain at single functional sequences, pain dimension is limited to any time of the daysevere: pain impairment of the quality of life at numerous activities of daily lifeextreme: marked impairment of the quality of life over 24h attached with clear pain description; previous treatment with NSAIDs with half-life of > 12 hours after a wash-out period of 5 times of half-life

E.4

Principal exclusion criteria

Acute inflammation; ischaemic necrosis; paget’s disease of the hip/knee joint; chondrocalcinosis of the hip/knee joint; ochronosis of the hip/knee joint; haematochromatosis of the hip/knee joint; hip/knee arthropathy in haemophiliacs; unilateral or bilateral inflammatory hip/knee arhtropathy as single manifestation (CP, Bechterew’s disease, psoriasis etc.) with and without involvement of other joints; infectious; slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology; hip/knee arthropathy due to diabetes mellitus; Charcot’s joint; villous sinovitis; chondromatosis of the synovium; contraindication of the trial substance (see SmPC); patients tending to allergies or hypersensitivity to non-steroidal anti-inflammatory agents (triggering asthma attacks or history of urticaria or acute rhinitis); patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months; patients with chronic respiratory tract infections, asthma; patients with impaired haematopoesis, porphyria, haemorrhagic diathesis; several renal or hepatic disease; uncontrolled hypertension (constant random diastolic blood pressure in spite of regular medication of at least two measurements > 180 and/or 110); severe heart failure (NYHA III-IV); decompensated diabetes mellitus (at requirement: bland-blood sugar over 400 mg/dl); patients with autoimmune disease (e.g. lupus erythematodes); positive urine pregnancy test at the onset of trial (if required); pregnant woman; breast-feeding woman; adolescents and children; participation in another clinical trial less than 30 days ago; simultaneous participation in another clinical trial

E.5 End points

E.5.1

Primary end point(s)

Safety and Tolerability based on gastrointestinal drug related Adverse Events

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 1-15

E.5.2

Secondary end point(s)

- Sum of pain intensity differences (SPID), time-weighted (0 to t):
For pain at night, pain after rising from resting position, pain at rest and pain on motion, using the visual analogous scale (VAS: horizontal 100mm) determined by calculating the pain intensity difference (PID) at each time point (t) from baseline.

SPID is calculated as the sum of the PIDs weighted over the time between observations as follows:

PID timet = pain intensity timet – pain intensity baseline

SPID = ∑ PID timet x [time (hours) elapsed since previous observation]

- Total pain relief (TOTPAR), time weighted (0 to t):
Is calculated as the weighted sum of pain relief scores on the 5-point verbal rating scale (VRS). For time to event data these measures are calculated as follows:

TOTPAR0-t: correspondingly calculated from the pain relief scores.

TOTPAR = ∑Rt x [time (hours) elapsed since previous observation]

Rt ……pain relief score at time t

- Peak PID, time to Peak PID, time to reduce baseline pain by at least 50% using the VAS:
The maximum PID from baseline (VAS) and total number of hours over which baseline pain was reduced by at least 50% using the VAS

Secondary criteria:

Also a global subjective judgement of tolerability and efficacy of therapy by investigator and patient on the basis of a five-point verbal rating score (VRS; 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor) on the trial exit day will be performed.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 1, Day 3 and Day 15

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

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

Yes

E.8.1.7.1

Other trial design description

Observer blinded

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

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

Information not present in EudraCT

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

End of trial is 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

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)

Yes

F.1.2.1

Number of subjects for this age range:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

500

F.4.2

For a multinational trial

F.4.2.1

In the EEA

500

F.4.2.2

In the whole clinical trial

500

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)

no difference from the expected normal treatment of that condition

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

2009-05-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-04-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-06-06

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