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    Summary
    EudraCT Number:2018-004305-11
    Sponsor's Protocol Code Number:DHRD/2018/079
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-05-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-004305-11
    A.3Full title of the trial
    Salbutamol for analgesia in renal colic: A prospective, randomised, placebo controlled Phase II trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Salbutamol for Analgesia in Renal Colic (SARC)
    A.3.2Name or abbreviated title of the trial where available
    Salbutamol for Analgesia in Renal Colic (SARC) v1.0
    A.4.1Sponsor's protocol code numberDHRD/2018/079
    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 SponsorUniversity Hospitals of Derby & Burton 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 supportNational Institute for Health Research (NIHR)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospitals of Derby & Burton NHS Foundation Trust
    B.5.2Functional name of contact pointDr Graham Johnson
    B.5.3 Address:
    B.5.3.1Street AddressEmergency Department, Royal Derby Hospital
    B.5.3.2Town/ cityDerby
    B.5.3.3Post codeDE22 3NE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01332 787867
    B.5.6E-mailgraham.johnson4@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 Ventolin Injection 500 micrograms in 1ml
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK 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 nameVentolin Injection 500 micrograms in 1ml
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSalbutamol
    D.3.9.1CAS number 18559-94-9
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive namen/a
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboInjection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Renal colic
    E.1.1.1Medical condition in easily understood language
    Kidney stones
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10038419
    E.1.2Term Renal colic
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore whether salbutamol improves the pain associated with renal colic, when added to the conventional pain relief for patients presenting to the emergency department with subsequently confirmed renal colic.
    E.2.2Secondary objectives of the trial
    To explore whether salbutamol improves the pain associated with renal colic, when added to the conventional pain relief for patients presenting to the emergency department with suspected renal colic.

    To assess the feasibility of conducting a definitive phase III multi-centre randomised controlled trial (RCT) of the cost and clinical effectiveness of salbutamol as an analgesic adjunct for patients with renal colic when added to the standard analgesic regime in the ED.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study Within A Trial:

    SWAT TITLE: dOes ParTicipant InforMatIon ShEet Design affect the recruitment rate into an interventional trial? A Study Within A Trial (OPTIMISED)

    SWAT Registration: This SWAT is registered as SWAT 32 on the MRC SWAT repository.

    Objectives:
    The primary objective for this SWAT is to explore whether improving the readability of a participant information sheet (PIS) has an effect on the recruitment rate into an interventional trial.
    The secondary objective of this SWAT will be to assess the impact, or “value”, of the PIS in the decision making of the patient.

    Outcomes:
    The primary outcome will be the proportion of patients who consent to take part in the interventional trial (known as the host study). Secondary outcomes will be qualitative measures, whereby consenting participants will provide feedback about the PIS they were provided. A questionnaire provided by Peter Knapp used in the “TRECA” study (a study of digital, multimedia resources used in recruitment to trials with children and adolescents) will be used to inform the development of a similar, decision making questionnaire to assess the impact or value of the PIS in the decision making of the patient.
    E.3Principal inclusion criteria
    1. Subjects capable of giving informed consent
    2. Age ≥18
    3. Working diagnosis of renal colic, as suggested by severe flank/unilateral abdominal pain, +/- radiating to suprapubic/groin area
    4. Experiencing severe pain with a requirement for intravenous analgesia
    E.4Principal exclusion criteria
    1. Abdominal aortic aneurysm not yet excluded and participant aged ≥50
    2. Ectopic pregnancy not yet excluded in a female of child-bearing potential
    3. Currently actively taking part in another CTIMP
    4. Previous participant in this trial
    5. Unable to understand verbal and/or written information in English
    6. Known allergy to salbutamol
    7. Evidence of sepsis or clinical suspicion of urinary tract infection
    8. Serum potassium <3.7mmol/l as measured on “point-of-care” venous blood gas
    9. Concomitant use of: beta blockers (including eye drops); prolonged release opiates; long-acting β-agonists
    10. Use of short-acting β2-agonists within the 6 hours preceding presentation to the emergency department
    11. Current arrhythmia
    12. History of any of:
    • ischaemic heart disease
    • arrhythmogenic heart disease
    • valvular heart disease
    • unilateral kidney
    13. Any other contraindication to the use of salbutamol
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the difference in the change in pain scores (measured on an 100mm Visual Analogue Scale [VAS]) from baseline to 30 minutes post drug administration between trial arms in patients with "Confirmed Renal Colic".
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes from time of IMP injection
    E.5.2Secondary end point(s)
    1. The difference in the change in pain scores (measured on an 100mm Visual Analogue Scale [VAS]) from baseline to 30 minutes post drug administration between trial arms in patients with "Suspected Renal Colic"
    2. The difference in the change from baseline pain score to pain scores at the following time points between trial arms: 15min, 60min, 120min, 240min, and then four-hourly thereafter, until 24 hours post drug administration or hospital discharge (whichever happens first) in both of the above subgroups.
    3. The difference in the change in qualitative pain description from baseline pain assessment to pain assessments at the following time points between trial arms as measured using the short-form McGill Pain Questionnaire: 15min, 30min, 60min, 120min post drug administration.
    4. Frequency and dose of morphine during the first 24 hours from enrolment (including prehospitally)
    5. Any other analgesics required and the timing of their administration
    6. Length of hospital stay
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 30 minutes post drug administration

    2. 15 minutes, 60 minutes, 120 minutes. Then four hourly from 4 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours (or hospital discharge, whichever is first), all from the time of drug administration.

    3. 15min, 30min, 60min, 120min post drug administration.

    4. Logged for the 24 hour study period, or until hospital discharge, whichever is first.

    5. Logged for the 24 hour study period, or until hospital discharge, whichever is first.

    6. Logged for the 24 hour study period, or until hospital discharge, whichever is first.
    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 No
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days16
    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: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state118
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 118
    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)
    There are no arrangements in place for the continued provision of treatment after completion of the trial.

    This is a Phase 2 study looking for any evidence of efficacy, rather than a definitive clinical trial that should change clinical practice.
    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 Decision2019-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-10
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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