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    Summary
    EudraCT Number:2012-000332-25
    Sponsor's Protocol Code Number:version1
    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:2012-05-28
    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 number2012-000332-25
    A.3Full title of the trial
    vitamin D replacement to prevent lung injury following oesophagectomy - a randomised controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    a trial of vitamin d treatment to prevent lung damage following surgery for oesophagel cancer.
    A.3.2Name or abbreviated title of the trial where available
    vitamin D replacement to prevent lung injury following oesophagectomy
    A.4.1Sponsor's protocol code numberversion1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN27673620
    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 Birmingham
    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 supportMRC
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointThickett
    B.5.3 Address:
    B.5.3.1Street AddressEdgbaston
    B.5.3.2Town/ citybirmingham
    B.5.3.3Post codeb15 2tt
    B.5.6E-maild.thickett@bham.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 Vigantol oil
    D.2.1.1.2Name of the Marketing Authorisation holdermerck
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namevigantol oil (cholecalciferol)
    D.3.2Product code NA
    D.3.4Pharmaceutical form Oral liquid
    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 INNcholecalciferol (vitamin D)
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive namevigantol oil
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5mg/ml
    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
    D.8.3Pharmaceutical form of the placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    perioperative inflammation in patients undergoing oesophagectomy.
    E.1.1.1Medical condition in easily understood language
    patients who need surgery for oesophageal cancer are at high risk of post-operative inflammation and lung damage due to the extent and duration of the surgery.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The aim of this study is to establish whether giving patients undergoing removal of the oesophagus for cancer vitamin d as a single dose reduces the inflammation and lung damage that occurs as a result of the surgical trauma. The primary outcome measure is the increase in lung water pre-post operative comparing dummy drug (placebo) with vitamin D. This is a marker of lung damage that is increased in patients following oesophagectomy.
    E.2.2Secondary objectives of the trial
    Secondary outcomes are safety and tolerability data- blood biochemistry, medication related side effects as well as markers of inflammation in the blood and bronchoalveolar lavage fluid that may be influenced by vitamin d.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • • Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre. • Men aged over 18 years on day of first dose of IMP • Women over the age of 55 or more than 2 years since menopause. • Women of potential child bearing age (under 55 and less than 2 years since menopause) may be recruited provided they agree to use contraception during the pre- post operative period (8 weeks). • Ability to give written informed consent to participate in the study.
    E.4Principal exclusion criteria
    • known intolerance of vitamin D. • known sarcoidosis, hyperparathyroidism, or nephrolithiasis. • taking more than 1000iu/day vitamin D supplementation in the month preceding enrolment. • known serum corrected calcium >2.65 mmol/L. • undergoing haemodialysis. • Pregnant or breastfeeding. • Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy. • Patients taking benzothiadiazine derivatives at doses higher than that which is recommended in the BNF • Patients taking benzothiadiazine derivative in combination with a calcium supplement • Patients with tuberculosis or lymphoma. • Individuals taking a dietary supplement containing > 1000 IU of vitamin D/day up to 1 months before first dose of IMP vitamin D will not be eligible to participate in the study and must not take additional supplements for the duration of the trial. • Diagnosis of COPD with an FEV1 less than 50% predicted or resting oxygen saturations of less 92%.
    E.5 End points
    E.5.1Primary end point(s)
    Post-operative extrascular lung water index. This will be measured at the end of the operation once one lung ventilation has ceased.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This will be assessed at the start of the operation, at the end (primary outcome) and daily post-operatively whilst the necessary central and arterial lines are in situ.
    E.5.2Secondary end point(s)
    Secondary endpoints are: 1) Clinical markers indicative of lung injury: P:F ratio, oxygenationindex, development of lung injury / ARDS day 0-28, duration of ventilation and organ failure,survival). 2) Safety and tolerability of vitamin D supplementation. 3) Plasma indices of endothelial and alveolar epithelial function/ injury. 4) Plasma inflammatory response. 5) Plasma LL-37 levels 6) plasma vitamin D status (25D3, 1,25D3 and VDBP) 7) EVLWI post-operative day 1
    E.5.2.1Timepoint(s) of evaluation of this end point
    preoperatively, post-operatively, and day 1 post-operatively.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 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 trial1
    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 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 study will be defined as the date of the final day of the final participant undergoing follow-up.
    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 months3
    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 months3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    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 vitamin D status will be communicated to the GP so that the patient can discuss lifestyle changes and or supplementation of vitamin D in the future.
    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 NA
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-01
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