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    Summary
    EudraCT Number:2014-005074-11
    Sponsor's Protocol Code Number:14/GAR/002
    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:2015-03-25
    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 number2014-005074-11
    A.3Full title of the trial
    The Role of GABAb receptor mechanisms in cough: Double-blind randomised controlled trial of Lesogaberan in Chronic cough patients with positive and negative symptom association probabilities
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-Blind Randomised Controlled Trial of Lesogaberan in Chronic Cough Patients

    This means patients will take Lesogaberan and a dummy drug (called placebo) in a random order. During the study neither the study doctor or patient will know whether they are taking Lesogaberan or placebo as the tablets will look identical.
    A.3.2Name or abbreviated title of the trial where available
    GARMIN-II: double-blind randomised controlled trial of lesogaberan in cough
    A.4.1Sponsor's protocol code number14/GAR/002
    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 Hospital South Manchester 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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Manchester
    B.5.2Functional name of contact pointJaclyn Smith
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, ERC
    B.5.3.2Town/ cityWythenshawe Hospital, Southmoor Rd
    B.5.3.3Post codeM23 9LT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01612915879
    B.5.5Fax number01612915730
    B.5.6E-mailjacky.smith@manchester.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 No
    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 nameLesogaberan (AZD 3355)
    D.3.2Product code AZD 3355
    D.3.4Pharmaceutical form Capsule
    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 INNLesogaberan
    D.3.9.1CAS number 344413-67-8
    D.3.9.3Other descriptive nameAZD3355
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 placeboCapsule, hard
    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
    Chronic cough
    E.1.1.1Medical condition in easily understood language
    Persistent cough
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of 2 weeks of Lesogaberan treatment compared with 2 weeks of placebo treatment on 24 hour cough frequency.

    Lay description:

    To test what effect a drug called Lesogaberan has on how much a person coughs in a 24 hour period compared to if that person was taking a dummy drug with no active ingredients (called placebo).
    E.2.2Secondary objectives of the trial
    There are 6 secondary objectives that need to be addressed:

    1) The effect of 2 weeks treatment with Lesogaberan on the cough response to capsaicin (chilli pepper). Do patients cough less times and are they less sensitive to the capsaicin?

    2) What is the effect of first dose of Lesogaberan on the cough response to capsaicin?

    3) The effect of Lesogaberan on the severity of cough and quality of life

    4) The effect of Leosgaberan on gastroesophageal reflux disease symptoms?

    5) The safety and tolerability of Lesogaberan in patients with chronic cough

    6) 24hr cough frequency for SAP positive vs. SAP negative patients after 2 weeks treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed, written and dated informed consent, prior to any study specific procedures.
    2. Aged above 18 years old.
    3. Agreement to comply with contraception restrictions as outlined in section 8.3.4
    4. BMI of 19-35 kg/m2 (inclusive)
    5. Normal spirometry.
    6. Chronic dry cough of at least 8 weeks duration.
    7. Normal chest X-ray.
    8. Patients with cough related to nasal disease, reflux and asthma will be included. These conditions will be investigated but they will still be included.
    E.4Principal exclusion criteria
    1. History of cardiac disease, clinically significant orthostatic reactions or syncope, renal disease and hepatic disease .
    2. Prolonged QTcF >450ms or family history of long QT syndrome at baseline (any prolongation of QTcF during the study will be classed as an AE unless >500 or deemed clinically significant by the research physician)
    3. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG at enrolment that may interfere with the interpretation of the QTc interval changes. This includes subjects with any of the following:
    • Clinically significant PR interval prolongation
    • Intermittent second or third degree AV block
    • Incomplete, full or intermittent bundle branch block (QRS<11ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
    4. Abnormal T wave morphology, particularly in the protocol define primary lead
    5. Any clinically significant illness, medical or surgical procedure or trauma within the 4 weeks preceding the first administration of study medication including upper respiratory tract infections.
    6. Any clinically significant abnormalities in clinical chemistry, haematology results as judged by the investigator.
    7. Abnormal screening clinical pathology values or other clinically significant, unexplained biochemical abnormality according to the investigator; in particular, liver function tests (LFTs) should be within normal limits at screening.
    8. Systolic blood pressure below 110 mm Hg at screening.
    9. Current smoker or ex-smoker with >20 pack year history, and <6 months abstinence.
    10. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class as Lesogaberan.
    11. History of drug addiction and/or alcohol abuse or other circumstances which in the investigators judgement may compromise the subject’s ability to comply with the study requirements.
    12. Pregnancy or breastfeeding.
    13. Treatment with ACE inhibitors will be excluded. Patients taking centrally acting medications e.g. opiates, amitriptyline, gabapentin, pregabalin for the treatment of cough, will be excluded unless they are willing to stop these treatments. Patients can be included if they are willing to stop opiates for 1 week prior to baseline visit through to follow-up visit. Pregabalin, gabapentin, amitriptyline and ACEi will need to be stopped for 4 weeks prior to baseline visit and through to follow-up visit.
    14. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of anticipated first administration of therapy in this study.
    E.5 End points
    E.5.1Primary end point(s)
    24 hour objective cough frequency following 2 week treatment with Lesogaberan compared with placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be calculated from the baseline cough frequency and the cough frequency on the final day of 2 weeks treatment.
    E.5.2Secondary end point(s)
    To determine the effects of Lesogaberan compared with placebo on:
    24hr cough frequency following one day’s treatment.
    Cough reflex sensitivity to capsaicin after 2 weeks treatment,
    Cough reflex sensitivity to capsaicin (on first treatment day) following one day’s treatment
    24hr cough frequency for (symptom associated probability) SAP positive vs. SAP negative patients after 2 weeks treatment
    24hr cough frequency for SAP positive vs. SAP negative patients on first treatment day,
    Cough severity VAS and cough specific quality of life.
    Measure of GORD symptoms
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described 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 Yes
    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) 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 No
    E.8.1.6Cross over Yes
    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.8.3 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 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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days1
    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: 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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 study participants will continue with their usual clinical treatment and follow-up via the cough clinic.

    Participants will be followed up for up 7-14 days after their last dose of the study drug. It will be made clear to patients that even if the study medication made a difference to their cough during the trial, once the trial treatment has finished, the medication will not be available at the end of the study. A paragraph regarding this has been included in the PIS.
    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 Decision2015-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-30
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