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    Summary
    EudraCT Number:2014-003412-37
    Sponsor's Protocol Code Number:323/12
    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:2019-08-22
    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 number2014-003412-37
    A.3Full title of the trial
    Improving outcomes for patients with hip osteoarthritis: a randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hip Injection Trial (HIT)
    A.3.2Name or abbreviated title of the trial where available
    Hip Injection Trial (HIT)
    A.4.1Sponsor's protocol code number323/12
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN50550256
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNHS
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKeele University
    B.5.2Functional name of contact pointStudy co-ordinator
    B.5.3 Address:
    B.5.3.1Street AddressKeele University
    B.5.3.2Town/ cityArthritis Research UK Primary Care Centre
    B.5.3.3Post codeST5 5BG
    B.5.4Telephone number01782734875
    B.5.5Fax number01782733911
    B.5.6E-maila.cherrington@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 Kenalog
    D.2.1.1.2Name of the Marketing Authorisation holderE.R.Squibb & Sons Ltd
    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 nameTriamcinolone Acetonide
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriamcinolone acetonide
    D.3.9.1CAS number 76-25-5
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive nameKenalog
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 1% Lidocaine Hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderHameln pharmaceuticals Ltd
    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 nameLidocaine Hydrochloride Injection BP 1%
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine Hydrochloride
    D.3.9.1CAS number 73-78-9
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    Hip osteoarthritis
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis (OA) is a degenerative joint disease that can affect any joint in the body, including the hips
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020108
    E.1.2Term Hips osteoarthritis
    E.1.2System Organ Class 100000004859
    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 compare longitudinal average mean pain scores over 6 months in people with hip osteoarthritis between those receiving best current treatment in addition to a steroid and local anesthetic injection with those receiving best current treatment alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are:
    To investigate whether a steroid and local anaesthetic injection and best current treatment is clinically effective at reducing symptoms and improving function compared to best current treatment alone in people with moderate to severe hip pain.

    To investigate whether a steroid and local anaesthetic injection and best current treatment is effective at reducing symptoms and improving function compared to a local anaesthetic injection and best current treatment in people with moderate to severe hip pain.

    To investigate whether a steroid and local anaesthetic injection and best current treatment is cost effective compared to best current treatment alone in people with moderate to severe hip pain, and whether it leads to a reduction in health care resource use or work absence over 6 months.

    To explore, in an interview study, the acceptability and impact of hip injections for people with moderate to severe hip pain.

    To explore, in an i
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There are 2 phases to a linked qualitative study. The objective of phase 1 is:

    To explore, in an interview study, the acceptability and impact of hip injections for people with moderate to severe hip pain.

    To explore, in an interview study, the experiences of patients living with hip OA

    The objective of the optional phase 2 qualitative study is:

    If recruitment is lower than anticipated, a linked interview study will explore reasons for non-participation in the trial and perceptions of recruitment processes with the aim of identifying modifiable barriers to recruitment.
    E.3Principal inclusion criteria
    1. Male or female aged ≥ 40 years
    2. A clinical diagnosis of unilateral or bilateral hip OA, and confirmed on plain radiography within the last 2 years, as made by a trained clinician in the musculoskeletal service
    3. Moderate to severe current hip pain (a score of 4 or more on a 0-10 numeric rating scale)
    4. Symptom duration of episode of at least 6 weeks
    5. Hip pain occuring on most days of the last month
    6. Informed written consent provided by the patient
    E.4Principal exclusion criteria
    Participants with the following characteristics are ineligible for the trial:
    1. Hip pain due to other disorders (e.g. trochanteric bursitis, avascular necrosis, pain referred from back)
    2. Intra-articular corticosteroid injection into the affected hip or ipsilateral trochanteric bursa injection within the proceding 3 months
    3. Any previous surgery on the affected hip
    4. Clinical suspicion of local or systemic sepsis or infection
    5. Current or previous infection of the affected hip
    6. Significant trauma to the affected hip requiring immobilisation in the previous 3 months
    7. Unwillingness to undergo study interventions
    8. Unable to understand and complete self report questionnaires written (or spoken) in English
    9. Significant illness (known or suspected) including, but not limited to:
    - inflammatory joint disease (e.g rheumatoid arthritis, seronegative spondyloarthropathy (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory-bowel disease associated with inflammatory arthritis))
    - polymyalgia rheumatica or other condition requiring regular oral steroid use
    - malignancy (where malignancy is thought to be causing hip pain eg. suspected bony metastases)
    - 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 (warfarin, dabigatran, rivaroxaban, low molecular weight heparin or apixaban)
    12. Any history of hypersensitivity to triamcinolone acetonide or 1% lidocaine hydrochloride or any of their excipients (1N Hydrochloric Acid QS, 1N Sodium Hydroxide QS, Benzyl alcohol. Polysorbate 80, Sodium carboxymethylcellulose and Sodium chloride).
    13. Contraindications to use of local anasesthetic: Complete heart block and hypovolaemia
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is severity of current hip pain as measured by a 0-10 Numerical Rating Scale (NRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will be followed up 2 weeks, 2 months, 4 months and 6 months after baseline.
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    A randomised, clinical, single blind, three-arm, parallel group pragmatic trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best current treatment
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 232
    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 state348
    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 trial, ongoing management of the participant's hip OA will be in accordance with standard care and should be considered by the participant's treating clinician or GP as appropriate.
    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 Decision2015-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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