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    Summary
    EudraCT Number:2011-004425-27
    Sponsor's Protocol Code Number:5863
    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:2012-05-03
    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 number2011-004425-27
    A.3Full title of the trial
    Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED)
    SORTED 1 – a Randomised Controlled Trial (Pilot study)
    SORTED 2 – Qualitative Interviews
    SORTED 3 – Retrospective Cohort
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to look at optimal levothyroxine dose in elderly hypothyroid patients
    A.3.2Name or abbreviated title of the trial where available
    SORTED
    A.4.1Sponsor's protocol code number5863
    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 SponsorNewcastle Upon Tyne Hospitals NHS Foundation Trust
    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 Research for Patient Benefit (RfPB) Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGateshead Health NHS Foundation Trust
    B.5.2Functional name of contact pointDr Salman Razvi
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Endocrinology, Queen Elizabeth Hospital
    B.5.3.2Town/ cityGateshead
    B.5.3.3Post codeNE9 6SX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01914456052
    B.5.5Fax number01914456186
    B.5.6E-mailsalman.razvi@ghnt.nhs.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 Eltroxin 25 micrograms tablets and Eltroxin 50 micrograms tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGoldshield 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 namelevothyroxine sodium
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevothyroxine sodium
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 micrograms to 150 micrograms
    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
    hypothyroidism (elderly individuals)
    E.1.1.1Medical condition in easily understood language
    thyroid gland does not make enough thyroid hormone
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    SORTED 1:
    • To assess participant’s willingness to enter the trial
    • To gauge participant’s acceptability of study design.
    • To study length of time required to complete recruitment.
    • To assess the dose titration strategy, described above, and length of time required to achieve desired TSH levels.
    • To gauge medication compliance.

    SORTED 2:
    • To explore the reasons for participation in a randomised control trial (SORTED 1 Study) amongst community dwelling people aged 80 years and over with levothyroxine treated primary hypothyroidism
    • To explore the reasons for non-participation in a randomised control trial (SORTED 1 Study) amongst community dwelling people aged 80 years and over with levothyroxine treated primary hypothyroidism
    • To examine the decision-making process that elderly people make in choosing whether to participate in a randomised control trial (SORTED 1 Study)
    • To explore aspects of health and well-being with differing doses of levothyroxine replaceme
    E.2.2Secondary objectives of the trial
    SORTED 1:
    • To measure the acceptability and usefulness of generic and validated disease-specific QoL questionnaires, EQ-5D, ThyDQoL and ThySC (Protocol Appendices A, B & C).
    • To assess mobility and risk of falls in this population group as measured by the Timed up and go test and the FRAT questionnaire - page 1 only (Protocol appendices D & E).
    • To measure change in specific cardiovascular risk factors such as lipid profile, blood pressure and body weight, and change in bone resorption marker.

    SORTED 3:
    For each patient identified, a number of other variables which are expected to be informative in the planning of a future full study will also be collected (see protocol appendix M).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    SORTED 1 Inclusion criteria:
    • Males and females aged 80 years or older
    • Diagnosed with hypothyroidism and treated with LT4 for at least 6 months
    • Living independently in the community
    • All TSH results within the range 0.4 – 4mU/L in the 3 months before commencing the study
    • Participant has provided written informed consent for participation in the study, prior to any study-specific procedures.


    SORTED 2 Inclusion criteria:
    • Individuals who have provided written informed consent to participate in the SORTED 1 Study (Group 1) or individuals who have been approached and who have formally declined to participate in the SORTED 1 Study (Group 2).

    Eligibility for SORTED 2 will already be verified via approach of the patient in relation to SORTED 1.

    SORTED 3:
    A total of 400 individuals who were 80 years or more in 2008 and were being treated for hypothyroidism.
    E.4Principal exclusion criteria
    SORTED 1 Exclusion criteria:
    • Established dementia and therefore deemed incapable of providing informed consent.
    • Other medical conditions which, in the opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound)
    • Nursing Homes or Residential Care Home residents
    • Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH
    • Individuals on 25 mcg daily of LT4: dose reduction will mean that they stop thyroid replacement treatment.
    • Non English speaking individuals.
    • Participation in any other investigational trials within the last 3 months.
    • Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil).
    • Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)
    E.5 End points
    E.5.1Primary end point(s)
    SORTED 1:
    • Participants willingness to enter the trial (consented participant to eligible participants approached ratio).
    • Participants acceptability of study design (as measured by the completion rate of participants in each randomised group).
    • Participant recruitment rate (as measured by the number of patients randomised divided by the length of the recruitment period. The recruitment period runs from the date that recruitment opened to the date of the last randomisation.
    • The dose titration strategy, described above, and length of time required to achieve desired TSH levels (number of participants in each group that reach target TSH range at both 12 and 24 weeks).
    • Medication compliance (tablet count).

    SORTED 2 (Objectives):
    • To explore the reasons for participation in a randomised control trial (SORTED 1 Study) amongst community dwelling people aged 80 years and over with levothyroxine treated primary hypothyroidism
    • To explore the reasons for non-participation in a randomised control trial (SORTED 1 Study) amongst community dwelling people aged 80 years and over with levothyroxine treated primary hypothyroidism
    • To examine the decision-making process that elderly people make in choosing whether to participate in a randomised control trial (SORTED 1 Study)
    • To explore aspects of health and well-being with differing doses of levothyroxine replacement for primary hypothyroid disease amongst community dwelling people aged 80 years and over.
    • To explore issues around retaining elderly people in a clinical trial (SORTED 1 Study) for its duration.

    SORTED 3: Assessment of mortality rate for L-thyroxine treated hypothyroid individuals aged 80 years or more over the subsequent 4 years.
    E.5.1.1Timepoint(s) of evaluation of this end point
    SORTED 1:
    • Participants willingness to enter the trial – screening only
    • Participants acceptability of study design – at final visit only
    • Participant recruitment rate – screening/baseline only
    • The dose titration strategy, described above, and length of time required to achieve desired TSH levels – visits 2 & visit 3
    • Medication compliance (tablet count) – visit 2 & visit 3

    SORTED 2 (Objectives):
    Assessed as per initial and follow-up interview (Group 1) or one-off interview (Group 2).

    SORTED 3:
    Assessed as per data provided via database search at GP practices.
    E.5.2Secondary end point(s)
    • The acceptability and usefulness of three patient completed questionnaires, a generic QOL questionnaire (EQ5D),a validated disease specific QoL questionnaire (ThyDQoL), and the disease specific hypothyroid symptom check list (ThySC). The time taken to complete the three questionnaires will be recorded and questionnaire completion rates will be calculated. Any third party help required in a questionnaire's completion will be recorded.
    • Assessment of mobility and risk of falls in this population group as measured by the nurse administered Timed Up and Go Test, and the Falls Risk Assessment Test – page 1 only for the FRAT).
    • Change in specific cardiovascular risk factors (lipid profile (Total cholesterol, High Density Lipoprotein,Triglycerides), blood pressure and body weight) and bone resorption marker (serum collagen type 1 cross-linked C-telopeptide).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • The acceptability and usefulness of three patient completed questionnaires, a generic QOL questionnaire (EQ5D), a validated disease specific QoL questionnaire (ThyDQoL), and the disease specific hypothyroid symptom check list (ThySC) – Baseline & Visit 3
    • Assessment of mobility and risk of falls in this population group as measured by the nurse administered Timed Up and Go Test, and the Falls Risk Assessment Test (page 1 only for the FRAT) – Baseline & Visit 3
    • Change in specific cardiovascular risk factors (lipid profile (Total cholesterol, High Density Lipoprotein,Triglycerides), blood pressure and body weight) and bone resorption marker (serum collagen type 1 cross-linked C-telopeptide) – Baseline & Visit 3
    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 Yes
    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
    Pilot Study
    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.8.2 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
    Comparator will be routine LT4 dose (Eltroxin - overencapsulated)
    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 concerned2
    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 study will be the last participant’s final study contact, at 25 weeks (+/- 3 days) post-randomisation (SORTED 1).

    Depending on whether the very last SORTED 1 participant is also a participant in SORTED 2 (Group 1), the end of study for the final participant will be approximately 26 weeks (+/- 7 days).

    It is anticipated that SORTED 3 will complete prior to SORTED 1.
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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.3.3.7.1Details of other specific vulnerable populations
    Elderly population (aged 80 years or older)
    F.4 Planned number of subjects to be included
    F.4.1In the member state468
    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)
    SORTED 1: At visit 3, participants on each arm of the study will stop their IMP and will be referred back to their GP to promptly prescribe the LT4 dose each participant was taking prior to study participation. The GP letter (sent once the participant is randomised) and the GP follow-up letter (sent after each participant completes their IMP) outlines the suggestion to recheck TSH levels after 3 months from stopping the IMP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Northumberland, Tyne and Wear CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-15
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