Clinical Trial Page

Summary
EudraCT Number:2006-002283-26
Sponsor's Protocol Code Number:Epikondylitt 2006
National Competent Authority:Norway - NOMA
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2006-11-08
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
A. Protocol Information
A.1Member State ConcernedNorway - NOMA
A.2EudraCT number2006-002283-26
A.3Full title of the trial
Physiotherapy alone, in combination with corticosteroid injection or wait-and-see for acute lateral epicondylitis in general practice: a randomised, placebo-controlled study with 12 months follow-up.
A.4.1Sponsor's protocol code numberEpikondylitt 2006
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorUniversity of Oslo, Institute of General Practice and Community Medicine
B.1.3.4CountryNorway
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Kenacort-T
D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
D.2.1.2Country which granted the Marketing AuthorisationNorway
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Injection*
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntralesional use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboInjection*
D.8.4Route of administration of the placeboIntralesional use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Lateral epicondylitis of the elbow
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10024032
E.1.2Term Lateral epicondylitis
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Objective
• To compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial
treatment of lateral epicondylitis in a primary care setting.
• To find the short and long term effect of physiotherapy with Mill’s manipulation, deep friction massage and
exercise therapy.
• Is this outcome influenced by corticosteroid injection, which has been shown to be of benefit alone in the short
term?
E.2.2Secondary objectives of the trial
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Age 18-70 years
Pain from the lateral part of the elbow
The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed
or the pain increases on resisted radial deviation of the wrist
or the pain increases on resisted extension of the 3. finger
E.4Principal exclusion criteria
Exclusion criteria
Duration of complaints less than 2 weeks or more than 3 months
The tenderness is located within the muscle body itself in the proximal part of the short radial extensor muscle of the
wrist (Cyriax type IV) 9.
Treament within the last 12 months for the same condition with corticosteroid injection or physiotherapy
Bilateral complaints
Previous surgical treatment for lateral epicondylitis
Deformities of the elbow (congenital or aquired)
Cervical radiculopathy or referred pain from neck or shoulder
Previous fractures or tendon ruptures in the elbow
Study protocol lateral epicondylitis version 18.04.2006 Page 4 of 6
Systemic musculoskeletal disease
Previous allergic reactions to corticosteroids or lidocain
Contraindications to corticosteroids or NSAIDs:
On-going or previous gastro-intestinal bleeding, previous ulcer or dyspepsia, severe asthma
on-going systemic infection, local skin-infection, recently vaccinated with live virus, coagulopathies, SLE, severe
liver- or kidney-disease, heart failure, diabetes, use of warfarin or NSAIDS
Pregnancy or breast-feeding
Fertile females not on effective birth control
Psyco-social or other reasons for not being able to participate throughout the study.
E.5 End points
E.5.1Primary end point(s)
The patient's evaluation of improvement after 6, 12, 26 and 52 weeks.
Pain, function and severity of main complaint after 6, 12, 26 and 52 weeks as recorded by the study doctors.
The patient's satisfaction with the treatment.
Time off work.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee No
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.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state170
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)
normal treatment
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2007-01-03
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-06-24
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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