Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-016873-13
    Sponsor's Protocol Code Number:PTHinCharcotfoot
    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:2010-03-17
    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 number2009-016873-13
    A.3Full title of the trial
    A novel therapy using recombinant human PTH 1-84 to stimulate bone repair and enhance fracture healing in the acute Charcot foot: a double blind placebo controlled phase IV trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to find out whether a special treatment called recombinant human parathyroid hormone 1-84 (rh PTH) can improve the bone repair and healing of bone fracture in the Charcot foot.
    A.3.2Name or abbreviated title of the trial where available
    A novel therapy using human PTH 1-84 in the acute Charcot foot
    A.4.1Sponsor's protocol code numberPTHinCharcotfoot
    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 SponsorKing’s College Hospital 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 supportDiabetes UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKings College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointInvestigator's Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressDenmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044203299 5124
    B.5.5Fax number0044203299 4536
    B.5.6E-mailnina.petrova@nhs.net
    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 Preotact
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed Denmark APS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePreotact
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEach dose of 71.4μl contains 100μg parathyroid hormone
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typePreotact contains parathyroid hormone manufactured using a strain of Escherichia coli modified by recombinant DNA technology.
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Charcot osteoarthropathy
    E.1.1.1Medical condition in easily understood language
    A disabling complication of diabetes, that results in deformity of the foot or ankle with the subsequent development of ulceration and infection that can ultimately lead to amputation.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10031173
    E.1.2Term Osteoarthropathy
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Can recombinant human parathyroid hormone (rh PTH 1-84) accelerate clinical resolution of the acute Charcot foot by enhancing bone repair and fracture healing. This will be asssessed in terms of:
    • Time to resolution of the acute Charcot foot
    • Percentage of patients with a clinical outcome of Charcot foot resolution by 6 months
    • Percentage of patients with a clinical outcome of Charcot foot resolution by 12 months
    E.2.2Secondary objectives of the trial
    Is there a difference in the percentage of patients that have achieved clinical resolution at 6 and 12 months between patients treated with rh-PTH compared with patients treated with standard treatment?
    Is there a difference in the percentage of patients with healed fractures on foot and ankle X-ray at clinical resolution between patients treated with rh-PTH compared with patients treated with standard treatment?
    Is there a difference in the percentage of patients with resolution of bone marrow oedema and bony union of fractures semi-quantitatively assessed on MRI at clinical resolution between patients treated with rh-PTH compared with patients treated with standard treatment?
    Is there a difference in the rate of change of bone turnover markers from baseline and up to clinical resolution of the Charcot foot between patients treated with rh-PTH compared with patients treated with standard treatment?
    Is there a difference in the rate of change of score in quality of life from ba
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for study participation if he or she meets the following criteria:
    1. Aged 18 to 75 years inclusive
    2. Has diabetes mellitus either Type 1 or Type 2
    3. Has acute Charcot osteoarthropathy defined as recent onset of a unilateral hot swollen foot with foot skin temperature 2oC greater than the contralateral foot. Patients should either have bone fracture and joint subluxation on standard foot and ankle x-rays or bone marrow oedema and bone microfracture on MRI.
    4. If female, is nonpregnant (negative pregnancy tests at the baseline visit) and nonlactating.
    5. If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practising one of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
    a. Oral, implantable or injectable contraceptives for 3 consecutive months before the baseline visit.
    b. Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the baseline visit).
    c. Intrauterine device
    d. Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
    6. Meets the following laboratory criteria:
    a. Aspartate aminotransferase (AST) within 3x the upper limit of normal.
    b. Glycated Haemoglobin A1C (HbA1C) < 12%
    c. Patients with eGFR> 30 ml/min and/or Creatinine clearance above 30 ml/min.
    7. Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

    E.4Principal exclusion criteria
    A patient will be excluded from the study if he or she meets the following exclusion criteria:
    1. Has active foot ulceration and infection
    2. Patients taking drugs that may affect calcium metabolism, patients on immuno-suppression, inhaled corticosteroids, anabolic steroids , other treatment for osteoporosis, rheumatoid arthritis.
    3. Patients with previous radiation therapy to skeleton, pre-existing hypercalcaemia, metabolic bone disease (including Paget’s and hyperparathyroidism)
    4. Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study.
    5. Has unexplained elevations of bone-specific alkaline phosphatase
    6. Has severe renal impairment defined as eGFR< 30 ml/min
    7. Has severe hepatic impairment defined as aspartate aminotransferase (AST) greater than 3x the upper limit of normal.
    8. Has pre-existing hypercalcemia and other disturbances in the phosphocalcic metabolism.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point will be to determine whether there is a difference between active treatment with rh PTH 1-84 and standard treatment alone in terms of:
    - Time to resolution of the Charcot foot
    - Percentage of patients with a clinical outcome of Charcot foot resolution by 6 months.
    - Percentage of patients with a clinical outcome of Charcot foot resolution by 12 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Percentage of patients with a clinical outcome of Charcot foot resolution by 6 months.
    - Percentage of patients with a clinical outcome of Charcot foot resolution by 12 months
    E.5.2Secondary end point(s)
    The secondary objectives will be to determine whether there is a difference between active treatment with rh PTH 1-84 and standard treatment alone in terms of:
    • Percentage of patients with healed fractures at clinical resolution on foot and ankle radiographs
    • Percentage of patients with bony union and healing of fractures at the time of clinical resolution on MRI scans
    • Rate of change of bone turnover markers from baseline and up to clinical resolution of the Charcot foot
    • Rate of change of score in quality of life from baseline up to clinical resolution using the SF-36
    • Rate of change of score in quality of life from baseline and up to clinical resolution using the EQ-5D;

    E.5.2.1Timepoint(s) of evaluation of this end point
    At Clinical Resolution or at the end of the trial.
    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.8.2.4Number of treatment arms in the trial2
    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
    The end of the trial will be the approval of protocol v4.0
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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) Yes
    F.1.2.1Number of subjects for this age range: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state46
    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)
    The patients will receive the standard care of treatment which is casting 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 Decision2010-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-25
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 14:42:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA