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    Summary
    EudraCT Number:2011-001312-59
    Sponsor's Protocol Code Number:CRO1824
    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:2011-04-15
    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 number2011-001312-59
    A.3Full title of the trial
    A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension
    A.4.1Sponsor's protocol code numberCRO1824
    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 SponsorImperial College London
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Qutenza
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameQutenza
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapsaicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number179
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTransdermal patch
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10037400
    E.1.2Term Pulmonary hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to determine: 1.The safety and tolerability of a single application of Qutenza® (capsaicin 8% patch) in pulmonary arterial hypertension patients. 2. The efficacy of a single application of Qutenza® (capsaicin 8% patch) in improving site pain caused by continuous SC infusion of Remodulin® in pulmonary arterial hypertension patients, relative to transparent adhesive control dressing (Tegaderm film 10cmx12cm) in combination with 0.075% capsaicin cream (Axsain®), as assessed by the change in Numerical Pain Rating Scale (NPRS) from baseline.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to determine: The efficacy of a single application of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary arterial hypertension patients, relative to transparent adhesive control dressing (Tegaderm film 10cmx12cm) in combination with 0.075% capsaicin cream (Axsain®), as assessed by: Patient Global Impression of Change (PGIC) relative to Remodulin® SC repositioning on the day of screening. The change in area of cutaneous hypersensitivity around the infusion site (optional and when feasible) [assessed using 1) cotton wool, 2) brush, 3) monofilaments, 4) pin prick and 5) thermal thresholds], relative to Remodulin® SC repositioning on the day of screening. The reduction in area of skin axon reflex vasodilatation (skin flare) around the infusion site (optional and when feasible) [assessed using 1) visual tracing of area of redness, and 2) laser Doppler fluxmetry], relative to Remod
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients 18 years or older with symptomatic PAH. 2.Willing to provide written informed consent to participate in the study. 3.With documented diagnosis of PAH, either idiopathic, familial or associated with connective tissue disease, congenital heart disease or the use of anorexogenic drugs. 4.Documented haemodynamic diagnosis of PAH by right heart catheterization – performed at any time prior to screening, showing: mean pulmonary arterial pressure >25 mm Hg, pulmonary capillary wedge pressure =/< 15 mmHg and pulmonary vascular resistance >240 dynes/sec/cm5. 5.Receiving stable doses of Remodulin® SC, continuously infused at a dose of at least 2.5 ng/kg/min for at least 8 weeks prior to enrolment. Additional medications that are approved for treatment of PAH (either bosentan or sildenafil) and other supplementary treatments such as oral anticoagulants, diuretics, digitalis, calcium channel blockers or oxygen supplementation are permitted. 6.History of pain at the site of Remodulin® SC infusion for at least 8 weeks prior to enrolment and as assessed on the 11 point pain intensity numerical pain rating scale (NPRS) from 0 to 10, where 0 represents “No pain" and 10 represents “Maximum pain imaginable”. Patients with a history of pain intensity equal or greater than 3 NPRS points (as determined by the NPRS trial diary completed during the screening period) are eligible to participate. [The use of systemic analgesics to relieve pain at the site of Remodulin® SC infusion, including salicylates, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, as well as topical analgesic-containing gels or creams (such as capsaicin 0.025% and 0.075% cream) and local anesthetics such as lidocaine are also permitted providing they remain unchanged for the entire duration of the study (i.e. from screening to the end of study follow up visit).] 7.Modified New York Heart Association (NYHA) (WHO) classification II-IV that has been stable for at least 8 weeks prior to enrolment. 8.A female subject is eligible to participate if she is of: •Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <40 pg/ml (<140 pmol/L) is confirmatory]. •Child-bearing potential and agrees to use one of the following contraception methods: oAbstinence oContraceptive Methods with a Failure Rate of < 1%: - Oral contraceptive, either combined or progestogen alone; - Injectable progestogen; - Implants of levonorgestrel; - Estrogenic vaginal ring; - Percutaneous contraceptive patches; - - Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label; - Male partner(s) sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study; - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus vaginal spermicidal agent (foam/gel/film/cream/suppository).
    E.4Principal exclusion criteria
    1.Patient’s participating in another clinical trial or who have done so within 30 days before screening. 2.Patients with PAH in NYHA/WHO functional class I at screening. 3.Known to be positive for human immunodeficiency virus (HIV). 4.Patients with any additional medical condition or illness that, in the opinion of the Investigator would interfere with study compliance and/or impair the patient's ability to participate or complete the study. Concurrent diseases or conditions that may interfere with study participation or safety include bleeding disorders, arrhythmias, organ transplant, organ failure, current neoplasm, poorly controlled diabetes mellitus, poorly controlled hypertension, clinically significant haematological or biochemical abnormality, and serious neurological disorders. 5.Patients with a history of substance abuse (e.g. alcohol or drug abuse) within the previous 6 months before enrolment. 6.Patients with a history of severe allergies or multiple drug allergies and/or reported hypersensitivity to capsaicin. 7.Patients with no history of pain at the site of Remodulin® SC infusion or average pain intensity at screening less than 3 points on the numerical pain rating scale (NPRS). 8.Life expectancy less than 12 months. 9.Unable to provide informed consent. 10.Female patients who are lactating or pregnant (positive pre-randomisation serum pregnancy test) or plan to become pregnant during the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure of safety will be based on the incidence, intensity and type of AEs and clinically significant changes in vital signs (pulse rate, blood pressure, respiration rate, pulse oximetry and temperature), and changes in concomitant medications throughout the study. Evaluation of safety will also be based on subject’s physical examination, signs and symptoms of PAH, routine clinical laboratory tests (hematology, chemistry, coagulation panel, and urinalysis), ECG, and NYHA (WHO) classification at the screening and end of study follow up visits.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Certain members of the study centre will be unblinded. It is these members who will apply treatment.
    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 Information not present in EudraCT
    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 is defined as the last patient’s last assessment.
    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 months0
    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 months0
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Patients with evidence or reduction of pain at the site of Remodulin subcutaneous infusion after the application of Qutenza patches either in period 1 or 2 will be prescribed Qutenza and followed up in the clinical service as required by current clinical practice.
    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 Decision2011-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-24
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