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    Summary
    EudraCT Number:2013-001435-48
    Sponsor's Protocol Code Number:464/11
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-03
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-001435-48
    A.3Full title of the trial
    The clinical and cost effectiveness of a steroid injection versus a night splint for Carpal Tunnel Syndrome: a pragmatic randomised trial in primary care
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Injections versus Splints in Carpal Tunnel Syndrome
    A.3.2Name or abbreviated title of the trial where available
    INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)
    A.4.1Sponsor's protocol code number464/11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKeele University
    B.1.3.4CountryUnited Kingdom
    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 supportArthritis Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKeele Primary Care Musculoskeletal Trials Unit (Keele CTU)
    B.5.2Functional name of contact pointClinical Studies Co-ordinator
    B.5.3 Address:
    B.5.3.1Street AddressArthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University
    B.5.3.2Town/ cityStaffordshire
    B.5.3.3Post codeST5 5BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01782 733909
    B.5.5Fax number01782 733911
    B.5.6E-maile.skinner@keele.ac.uk
    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 Depo-Medrone
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameDepo-Medrone
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethylprednisolone Acetate
    D.3.9.1CAS number 53-36-1
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive nameDepo-Medrone
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carpal Tunnel Syndrome (CTS)
    E.1.1.1Medical condition in easily understood language
    Condition in which the nerve is squeezed where it passes through the wrist, causing pain, aching, tingling or numbness in the affected hand.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007697
    E.1.2Term Carpal tunnel syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007697
    E.1.2Term Carpal tunnel syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052414
    E.1.2Term Unilateral carpal tunnel syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are:
    •To investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the medium term (6 months) compared to a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care.
    •To investigate whether a steroid injection is cost-effective compared with a night splint in people consulting with mild to moderate carpal tunnel syndrome in primary care, and whether it leads to a reduction in health care resource use or work absence over 6 months.
    •Subject to further funding, participants will be followed-up over the longer term for 24 months to examine differences across the whole 24 month follow-up period in:
    o health care resource use or work absence
    o patterns in specific clinical outcomes (Boston CTS questionnaire and pain intensity NRS)
    o referral for CTS surgery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Factors, both medical and non-medical, will be taken into account including whether a patient will be able to participate in the trial.
    1.Male or female aged ≥ 18 years
    2.A clinical diagnosis of unilateral or bi-lateral CTS as made by a GP or trained clinician according to the diagnostic criteria
    3.Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
    4.Symptom duration of episode of at least 6 weeks
    5.Written informed consent provided by the patient, prior to any trial specific procedures
    E.4Principal exclusion criteria
    Participants with the following characteristics are ineligible for the trial:
    1.Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
    2.Any previous surgery on the affected wrist
    3.Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion
    4.Clinical suspicion of local or systemic sepsis or infection
    5.Current or previous infection of the affected wrist
    6.Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
    7.Unable to tolerate the study interventions
    8.Unable to understand and complete self-report questionnaires written in English
    9.Inter-current illness including, but not limited to:
    •poorly controlled thyroid disease
    •poorly controlled diabetes mellitus
    •vibration-induced neuropathy
    •inflammatory joint disease
    •suspected complex neurological conditions
    •any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
    10.Pregnant or lactating females
    11.Receiving anticoagulants
    12.Any history of hypersensitivity to Depo-Medrone or any of its excipients (refer to the Summary of Product Characteristics (SPC))
    13.Allergy to any of the splint materials
    14.Known abuse of drugs or alcohol
    15.Involved in on-going litigation cases for their condition
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the study is symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is at 6 weeks post-randomisation.

    The primary outcome measure will also be assessed at 6 weeks, 6-, 12-, and 24-months post randomisation.
    E.5.2Secondary end point(s)
    Secondary outcome measures are as follows:
    •Hand-wrist symptom intensity (0-10 numerical rating scale)
    •Interrupted sleep
    •Adherence to splinting where indicated
    •Patients’ perceived benefit and satisfaction with treatment
    •Impact of CTS on work and other activities (including work absence and reduction in performance measured by a 0-10 rating scale for work performance)
    •Referral for surgery
    •General health (EQ-5D-5L)
    •Health care utilisation and patient incurred costs
    •Use of co-interventions such as supplements, pain relief, etc

    Participants’ expectations regarding treatment response will be explored as potential effect modifiers. Adherence to treatment will be captured in the participant questionnaires (in particular use of the splint).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary outcome measures will assess outcomes at 6 weeks, 6-, 12-, and 24-months post randomisation.
    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 Yes
    E.6.13.1Other scope of the trial description
    Effectiveness
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Wrist splint
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of the trial is defined as the collection of the last data item for the last participant to be randomised.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state240
    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)
    At the end of the intervention phase of the study, ongoing management of the participant's CTS will be in accordance with standard care and should be considered by the participant's treating clinician or GP as appropriate. Participants allocated to the splint arm will be able to keep their splint should they wish to.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-26
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