Clinical Trials Register

Summary
EudraCT Number:	2013-003365-34
Sponsor's Protocol Code Number:	Artralgia1
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-08-27
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

Sweden - MPA

A.2

EudraCT number

2013-003365-34

A.3

Full title of the trial

Pain relief following an intra-articular single dose metylprednisolon vs. placebo on temporomandibular joint artralgia patientens. A randomized controlled blinded multicenter study.

Smärtlindring efter en intra-artikulär injektion av metylprednisolon vs. placebo på patienter med artralgi i käkleden. En randomiserad kontrollerad blindad multicenter studie.

A.3.1

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

Pain relief following a single dose metylprednisolon vs. placebo injected to the jaw joint in patientens with chronic joint pain. A randomized controlled blinded multicenter study.

Smärtlindring efter en injektion av metylprednisolon vs. placebo på patienter med smärtande käkleder. En randomiserad kontrollerad blindad multicenter studie

A.3.2

Name or abbreviated title of the trial where available

Metylprednisolon temporomandibular joint

Metylprednisolon käkled

A.4.1

Sponsor's protocol code number

Artralgia1

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	Specialisttandvårdskliniken Västmanlands sjukhus Västerås
B.1.3.4	Country	Sweden
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	Landstinget Västmanland
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	Örebro Läns Landsting
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	Folktandvården Stockholm AB
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	Landstinget Sörmland
B.4.2	Country	Sweden
B.4.1	Name of organisation providing support	Regionala forskningsrådet i Uppsala- och Örebroregionen
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Specialisttandvårdskliniken Västmanlands sjukhus Västerås
B.5.2	Functional name of contact point	Göran Isacsson
B.5.3	Address:
B.5.3.1	Street Address	Ingång 27
B.5.3.2	Town/ city	Västerås
B.5.3.3	Post code	72129
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46767766506
B.5.6	E-mail	goran.isacsson@ltv.se

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	Depo-Medrol 40 mg/ml injektionsvätska, suspension
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intraarticular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Artralgia of the jaw joint

Artralgi i käkleden.
Deskriptiv klinisk diagnos med smärta från käke-ansikte och där det onda förvärras vid tuggning av seg och hård föda. Gapning är smärtsam

E.1.1.1

Medical condition in easily understood language

Undefined pain from jaw joint

Ospecifik smärta i käkleden.
Deskriptiv klinisk diagnos med smärta från käke-ansikte och där det onda förvärras vid tuggning av seg och hård föda. Gapning är smärtsam

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

The primary objective is to evaluate the relief of pain at maximal mouth opening following a single dose intra-articular metylprednisolon (Depo-Medrol®) vs. placebo in patients with artralgia of the temporomandibular joint

Målsättningen är att utvärdera graden av smärtlindring vid maximal gapning efter en engångsinjektion I.A. metylprednisolon (Depo-Medrol®) vs. placebo på patienter med käkledsartralgi en månad efter behandling

E.2.2

Secondary objectives of the trial

The secondary objectivs are to evaluate the relief of jaw pain at rest, mouth opening, jaw function, the consequences of pain and the emotional influence following the treatment. Also the variability of pain 3 days before and 5 days after the treatment as well as during 3 days before end of a one month evaluation period is tracked.

Sekundärt utvärderas smärtlindringen vid käkvila, gapförmåga, käkfunktion, konsekvensen av smärta, och inverkan på stämningstillståndet av smärtlindringen. Också smärtans variabilitet 3 dagar före, 5 dagar efter injektionen och under 3 dagar en månad efter behandlingen beskrivs.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

age 18 or above
the diagnosis artralgia in one jaw joint
understands Swedish verbally and in written
signed informed concent

• ålder > 18 år.
• diagnosen artralgi i en käkled
• förstår svenska muntligen och skriftligen
• skriftligen gett sitt medgivande att delta

E.4

Principal exclusion criteria

noise from affekted joint( clicking or crepitation)
polyarthitis/connective tissue disease
bilateral artralgia of jaw joint
fibromylagia or other generalized pain
ongoing virus or bacterial infection
ongoing major restaurations in the mouth
corticosteroid injection in affekted jaw joint past 6 months
previous sugical intervention of affected jaw joint
complex psychiatric or psychological condition
hypersensitive to local anesthetics
hypersensitive to metylprednisolone
hemofilia

• käkledsljud (knäppning eller krepitation)
• polyartrit/bindvävssjukdom
• bilateral artralgi
• fibromyalgi eller annan generaliserad smärta
• pågående virus- eller bakterieinfektion
• pågående tandvårdsbehandling
• kortikosteroidinjektion i käkleden de senaste sex månaderna
• tidigare kirurgi av besvärande käkled
• komplex psykiatrisk/psykologisk bild
• överkänslighet mot lokalanestetika
• överkänslighet mot metylprednisolon
• hemofili

E.5 End points

E.5.1

Primary end point(s)

The differnce in VAS-rated pain intensity at maximal mouth opening from baseline to end of study

Förändringen av VAS-skattad smärta vid maximal gapning mellan baseline och studieslut efter en månad.

E.5.1.1

Timepoint(s) of evaluation of this end point

After a month

Efter en månad.

E.5.2

Secondary end point(s)

The differnce in VAS-rated pain intensity at jaw rest from baseline to end of study
Maximal opening without pain
Maximal opening with pain
Maximal assisted mouth opening
Instruments
JFLS
GCPS
PHQ-9
PGIC

Förändringen av VAS-skattad smärta vid käkvila
Maximal gapning utan smärta
Maximal gapning med smärta
Maximal gapning med assistans

Instrument
JFLS: En 0- 10 gradig käkfunktionsskala med 20 frågor där patienten graderar sin begränsning av käkfunktionen senaste månaden.
GCPS: Ett instrument med 8 frågor där patienten svarar på hur smärtan på en 0-10 gradig skala på 6 av frågorna har påverkat smärtan och dess konsekvenser. Två av frågorna tar upp durationen av smärtan.
PHQ-9: Ett instrument med en 4-gradig skala och 9 frågor som beskriver stämningsläget hos patienten.
PGIC: Ett instrument som används vid studiens slut och där patienten svarar på frågan "Hur har din smärta förändrats jämfört med tiden före injektionen? Patienten ringar in det som bäst beskriver situationen i genomsnitt" och markerar ett av 7 svarsalternativ "väldigt mycket bättre, mycket bättre, lite bättre, oförändrad, lite sämre, mycket sämre, väldigt mycket sämre

E.5.2.1

Timepoint(s) of evaluation of this end point

After a month

Efter en månad.

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

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

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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.1.1.1

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-08-27.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

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

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)

Patients treated following the routine at the clinic with an algorithm adapted to the particular diagnose

Patienterna behandlas enl den rutin som gäller på kliniken och den algoritm som är anpassad till den aktuella diagnosen

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

2013-10-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-09

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

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