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    Summary
    EudraCT Number:2012-001381-15
    Sponsor's Protocol Code Number:RICH-ART
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-23
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-001381-15
    A.3Full title of the trial
    Radiation Induced Cystits treated with Hyperbaric Oxygen. A Randomized controlled Trial
    Trykkammer behandling for lidelser i blæren forårsaget af strålebehandling –
    Et randomiseret kontrolleret forsøg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hyperbaric chamber treatment of disorders of the bladder caused by radiation therapy of cancer in the pelvic region
    Trykkammer behandling for lidelser i blæren forårsaget af strålebehandling af kræft i bækkenpartiet
    A.4.1Sponsor's protocol code numberRICH-ART
    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 SponsorSahlgrenska University Hospital Västra Götalandsregionen
    B.1.3.4CountrySweden
    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 supportSahlgrenska University Hospital Västra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointOle Hyldegaard
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityKøbenhavn Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535453545
    B.5.5Fax number4534454231
    B.5.6E-mailole.hyldegaard@regionh.dk
    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 Conoxid 100 %, Medicinsk Oxygen, Kryogen
    D.2.1.1.2Name of the Marketing Authorisation holderAGA A/S
    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 nameMedicinsk Oxygen
    D.3.4Pharmaceutical form Medicinal gas, cryogenic
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRespiratory use (Noncurrent)
    Inhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.1CAS number 7782-44-7
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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 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 Yes
    D.3.11.13.1Other medicinal product typeOxygen
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Radiation Cystitis
    Strålingsfremkaldt cystitis
    E.1.1.1Medical condition in easily understood language
    Disorders of the bladder caused by radiation therapy of cancer in the pelvic region
    Lidelser i blæren forårsaget af strålebehandling af kræft i bækkenpartiet
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10057480
    E.1.2Term Hyperbaric oxygen therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable
    Det primære formål med denne undersøgelse er, at vurdere symptomlindring efter HBO behandling hos patienter med sen stråle cystitis ved, at have EPIC symptom estimerings skala som primær variabel
    E.2.2Secondary objectives of the trial
    •To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable
    •To assess the severity of radiation injury having the RTOG-scale as variable
    •To assess health-related quality of life before and after HBO therapy having SF-36 as the variable
    •At undersøge blærens mucosa med hensyn til funktionaliteten ved vurdering af inflammations aktivitet, kvantificering af fibrose, vaskulær densitet og tilstedeværelsen af stamceller med histologisk analyse af biopsier som variabel
    •At vurdere alvorligheden af stråleskader, der har RTOG-skalaen som variabel
    •At vurdere sundhedsrelateret livskvalitet før og efter HBO behandling med SF-36 som variabel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Provision of informed consent prior to any study specific procedures
    - Female or male aged 18-80 years
    - Intended curative radiation of the pelvic region as a treatment for cancer
    - End of radiation therapy more than 6 months ago
    - Radiation cystitis with Urological EPIC < 80
    -Radiation cystitis is the most probable cause for the patient’s symptoms
    -Der skal opnås informeret samtykke til alle procedurer i forbindelse med studiet
    -Kvinde eller mand i alderen 18-80 år
    -Skal have gennemgået en kurativt intenderet strålebehandling af en cancersygdom i bækkenet
    -Strålebehandlingen skal være afsluttet for mere end 6 måneder siden
    -Patienten skal have en strålecystit med symptomer svarende til urologisk EPIC <80.
    -Stråleinduceret cystit er den mest sandsynlige årsag til patientens symptomer.
    E.4Principal exclusion criteria
    - Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks)
    - Refractory incontinence requiring catheter or surgical intervention
    - Urine bladder capacity < 100ml
    - Fistula in the urine bladder
    - Contraindications for HBO therapy according to the local centres routines
    - Pregnancy
    - Mechanical ventilator support
    - Unable to follow and understand simple commands
    - Not oriented to person, place and time
    -Patienter med svære og vedvarende blødninger fra blæren (kræver mere end 0,5 l blodtransfusion inden for de sidste fire uger)
    -Refraktær inkontinens, som kræver kateter eller kirurgisk indgreb
    -Urinblærens kapacitet <100ml
    -Fistel i urinblæren
    -Kontraindikationer for HBO behandling i henhold til de lokale centres rutiner
    -Graviditet
    -Respiratorbehandling
    -Ude af stand til at følge og forstå simple kommandoer
    -Ikke orienteret i tid, sted og egne data
    E.5 End points
    E.5.1Primary end point(s)
    The primary endoint is symptom rating after HBO therapy using the self-administrated EPIC-questionnaire original score as the primary variable
    Det primære endpoint i dette studie er symptombedømmelse efter HBO behandling med det selv-administrerede EPIC-spørgeskema. Scoringen ved første besøg er den primære variabel
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at Visit 4, 6-8 weeks after finalized treatment
    Ved baseline og besøg 4, 6-8 uger efter afsluttet behandling
    E.5.2Secondary end point(s)
    •Severity of radiation injury having the RTOG as the variable at baseline and visit 4
    •Histological analysis of inflammation activity, degree of fibrosis, vascular density and the presence of stems cells at baseline and visit 4.
    •Health-related quality of life (SF36) at baseline visit 3, 4 and 5
    •Post-study long-term follow-up follow up with Symptom rating (EPIC) and Health-related quality of life (SF36)
    •Graden af stråleskader, der har RTOG som variabel ved baseline og besøg 4
    •Histologisk analyse af inflammatorisk aktivitet, graden af fibrose, vaskulær densitet og tilstedeværelsen af stamceller ved baseline og besøg 4
    •Helbredsrelateret livskvalitet (SF36) ved baseline besøg 3, 4 og 5
    •Efter-undersøgelse i forbindelse med langsigtet opfølgning med symptom rating (EPIC) og helbredsrelateret livskvalitet (SF36)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline (visit 1) and 6-8 months (visit 4).
    SF-36 also immediately after finalized HBOT (visit 3 and 5)
    Long-term follow-up: 5 years after finalized study
    Baselinee (besøg 1) og 6-8 måneder (besøg 4).
    SF-36 også straks efter endt HBOT (besøg 3 og 5).
    Opfølgning: 5 år efter sidste studiebesøg.
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    Forsinket start som kontrol
    Delayed start as control
    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
    Forsinket start: Gruppe B starter behandling 6-8 måneder efter Gruppe A for at udgøre
    Delayed start: Group B will start treatment 6-8 months after Group A to work as control
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Last patient last visit (LVLS). A post-study 5 year follow-up will be made
    Sidste patients sidste besøg (LVLS). Alle patienter (gruppe A og B) vil blive kontaktet for en efter-studie-undersøgelse
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    All patients will receive HBO treatment within the frame of the clinical study. The Group B patients will be contacted by telephone or via mail for completion of EPIC and SF36 after 6-8 months after the last study visit. All patients (Group A and B) will be contacted for a post-study long-term follow-up after 5 years regarding symptoms (EPIC) and quality of life (SF-36). Otherwise routine treatment for this patient group will continue within the health care.
    Alle patienter (gruppe A og B) modtager HBO behandling inden for rammerne af den kliniske undersøgelse. Opfølgning af gruppe B-patienter vil finde sted efter afsluttet studie via telefon eller mail for færdiggørelse af EPIC og SF36 6-8 måneder efter det sidste besøg. Alle patienter (gruppe A og B) kontaktes for en efter-studie-undersøgelse til udfyldelse af skemaerne vedr. symptomer (EPIC) og livskvalitet (SF-36). Derudover tilbydes almindelig standard behandling i sygehusregi.
    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 Decision2014-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
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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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