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    Summary
    EudraCT Number:2017-003767-35
    Sponsor's Protocol Code Number:MR311-3501
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-29
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2017-003767-35
    A.3Full title of the trial
    A randomised, double-blind, parallel group study comparing patient controlled analgesia with Penthrox® (methoxyflurane) versus placebo during colonoscopy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To evaluate the safety and efficacy of Penthrox® (methoxyflurane) for the treatment of pain during colonoscopy
    A.3.2Name or abbreviated title of the trial where available
    MEthoxyflurane in Acute coloNoScopy pain: MEANS randomised controlled trial
    A.4.1Sponsor's protocol code numberMR311-3501
    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 SponsorMundipharma Research Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMundipharma Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMundipharma Research Limited
    B.5.2Functional name of contact pointMedical Operations
    B.5.3 Address:
    B.5.3.1Street AddressCambridge Science Park, Milton Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB4 0AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223424900
    B.5.5Fax number+441223425794
    B.5.6E-mailclinicaltrials@mundipharma-rd.eu
    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 PENTHROX
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma France
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePENTHROX
    D.3.2Product code MR311
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHOXYFLURANE
    D.3.9.1CAS number 76-38-0
    D.3.9.2Current sponsor codeMR311
    D.3.9.3Other descriptive namePENTHROX
    D.3.9.4EV Substance CodeSUB08858MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number99.9
    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 Yes
    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 placeboInhalation vapour, liquid
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain relief during colonoscopy
    E.1.1.1Medical condition in easily understood language
    Pain
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 primary objective is to demonstrate superiority in the efficacy of Penthrox (methoxyflurane) versus placebo based on mean pain profile during colonoscopy, a difference of 1.5 between the two groups can be regarded as clinically meaningful.
    E.2.2Secondary objectives of the trial
    · Compare efficacy of Penthrox (methoxyflurane) versus placebo based on the key secondary endpoints
    · Compare the impact on the procedure based on other secondary endpoints
    · Compare the safety of Penthrox (methoxyflurane) versus placebo based on the safety endpoints
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Referred for colonoscopy for clinical indications or cancer screening
    2.Males and females, age ≥ 18 years.
    3.Female Subjects less than one year post-menopausal must have a negative urine pregnancy test prior to the first dose of study medication, and be non-lactating.
    4.Written informed consent obtained from the Subject indicating that they understand the purpose of, and procedures required, for the study and are willing to participate in it.
    5.Ability to understand the use of the Penthrox (Methoxyflurane) inhaler.
    E.4Principal exclusion criteria
    1.Pregnancy or lactation period (women only)
    2.Previous colorectal resections
    3.Same-day bi-directional endoscopy
    4.Subjects having a pain score (pain right now) > 2 as assessed by a NRS score (0 – 10) at baseline
    5.Subjects with any condition e.g. extreme anxiety judged by the Investigator to interfere with correct administration of Penthrox (Methoxyflurane) inhaler
    6.Diagnosed anxiety disorders
    7.Concomitant treatment with psychotropic drugs including benzodiazepines
    8.Active alcohol or drug abuse and/or history of opioid abuse
    9.Renal impairment defined as creatinine >1.5 x ULN measured at screening
    10.Subjects taking any potential nephrotoxic drugs (e.g. aminoglycosides)
    11.Uncontrolled diabetes mellitus as evidenced by HbA1c > 8% at screening or known diabetic nephropathy
    12.Evidence of clinically significant disease e.g. liver, cardiac, respiratory or malignant disease (e.g., ischemic heart disease, chronic obstructive pulmonary disease, chronic liver disease) based on Investigator assessment of medical notes and/or subject recall, physical examination, laboratory and ECG assessments conducted at screening with ASA 3 or higher
    13.Previous possible allergy to the study medication by the subject or relative
    14.Any history of hypersensitivity to fluorinated agents
    15.Concomitant head injury
    16.Unconsciousness
    17.Personal or family history of malignant hyperthermia
    18.Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
    19.Subjects who are incapable of giving informed consent or complying with the protocol.
    20.Subjects who have a history of showing signs of liver or kidney damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia.
    21.Requiring treatment with any prohibited concomitant medications
    22.Use of any premedication before the procedure e.g. with sedative or analgesic medications within 24 hours before colonoscopy
    E.5 End points
    E.5.1Primary end point(s)
    Worst pain measured on NRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every two minutes until caecum (way in), every 5 min after reaching the caecum (way out), and immediately after colonoscopy
    E.5.2Secondary end point(s)
    · Number of responders; a responder is defined as a Subject with an average pain ≤ 3 (mild pain) covering the whole colonoscopy procedure without intake of rescue medication
    · Pain score at discharge measured on NRS (pain right now)
    · Anxiety scores before and during procedure measured using STAI-AD and VAS-F.
    · Need for rescue medication (no of Subjects / amount)
    · Subject, nurse and colonoscopist satisfaction measured using comfort scale.
    Other secondary endpoints:
    · Subject willingness to undergo the same procedure
    · In-room preparation time measured as time from entering procedure room to start of colonoscopy
    · Caecal intubation rate measured as (caecum reached? yes/no)
    · Caecal intubation time measured as time from start of procedure to reaching the caecum
    · Total colonoscopy time measured as time from start to end of procedure
    · Rate of polyp and adenoma detection measured as total number detected
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the descriptions of the endpoints above.
    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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state55
    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)
    None
    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 Decision2018-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-12
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