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    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-002284-13
    Sponsor's Protocol Code Number:CRx-197-003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-10-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-002284-13
    A.3Full title of the trial
    A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO ASSESS THE ANTI-INFLAMMATORY PROPERTIES OF TOPICAL CRX-197 IN LESIONAL SKIN OF ADULT SUBJECTS WITH MILD TO MODERATE ATOPIC DERMATITIS
    A.4.1Sponsor's protocol code numberCRx-197-003
    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 SponsorCombinatoRx, Incorporated
    B.1.3.4CountryUnited States
    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 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 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 nameCRx-197 topical cream
    D.3.4Pharmaceutical form Cream
    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 INNloratadine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnortriptyline
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    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 name0.1% nortriptyline
    D.3.4Pharmaceutical form Cream
    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 INNnortriptyline
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 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
    mild to moderate atopic dermatitis
    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 of this study is to demonstrate the effectiveness, tolerability and safety of CRx-197 in subjects with mild to moderate AD.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following inclusion criteria:

     I01 Subject must voluntarily give written informed consent
     I02 Subject must be 18 to 60 years of age
     I03 Subject must manifest mild to moderate AD diagnosed according to Hanifin and Rajka [Hanifin, 1980]
    • Two Lesional areas of 20-50 cm2
     ADSI lesional score ≥4 and <13
    • Difference in ADSI lesional score between lesions treated in the same subject should not be greater than 1
     I04 TEWL in the lesional areas at least 12 g/m2h
     I05 Subject must be free from a condition/disease that the investigator feels will interfere with the interpretation of the study results.
     I06 Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
    E.4Principal exclusion criteria
    Subjects will be excluded from study entry if any of the following exclusion criteria exist at the time of enrolment or after obtaining Screening laboratories:
    Medical History:

     E01 Acne, suntan, dermatitis, hyper- or hypopigmentation other than atopic dermatitis, or tattoos in the treatment areas that would prevent ready assessment of skin reaction
     E02 Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
     E03 Mania or acute delirium or epilepsy
     E04 Narrow angle glaucoma
     E05 Hyperthyroidism by medical history, TSH less than the LLN, or subject receiving any thyroid medication
     E06 Diabetes (both insulin and non-insulin dependent)
     E07 Liver disease - ALT laboratory value that exceeds 1.5x ULN
     E08 Visible Bacterial, viral or fungal skin infections (at the test areas); or inflammatory dermatoses (at the test areas); or facial rosacea
     E9 Known allergic reactions or hypersensitivity to any of the components of the study preparations
     E10 Known severe kidney disease, acute urinary retention, prostatic hypertrophy with post-void residual urine or laboratory value of creatinine that exceeds 1.5x ULN
     E11 Significant gastrointestinal diseases including but not limited to pyloric stenosis or paralytic ileus
     E12 Active varicella, tuberculosis, syphilis or post-vaccine reactions
     E13 Autoimmune disease (e.g. lupus erythematosis)
     E14 Ultraviolet (UV) therapy or significant UV exposure in the four weeks before treatment application or for the duration of the study
     E15 History of malignancy (except for treated or excised basal cell carcinoma)
     E16 History of drug or alcohol abuse (as defined by the Investigator)
     E17 Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study
     E18 Subject with demonstrated hypokalemia (less than LLN)
    Infection History:

     E19 Positive for HIV antibody
     E20 Positive for hepatitis B surface antigen (HBbsAg)
     E21 Positive for hepatitis C (HCV)

    Treatment History:

     E22 Subjects who require medications that inhibit the cytochrome P450 (CYP450) 2D6 pathway such as:
    • Quinidine
    • Cimetidine
    • Type 1 anti-arrhythmics
    • Phenothiazines
    • Selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, or sertraline
    • Reserpine, other anticholinergic drugs, or sympathomimetic drugs
     E23 Systemic treatment or locally acting medication which might counter or influence the study aim (e.g. immunomodulators azothioprine or cyclosporine, corticosteroids or medications that influence liver function) in the four weeks prior to first study treatment (exception: corticosteroid inhalation for asthma will be allowed at a dose not exceeding 1 mg/day)
     E24 Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as:
    • MAO inhibitors
    • Anti-depressants
    • Anti-seizure medications
    • Anti-psychotics
    • Anti-histamines
    • Anti-coagulants
    • Anti-mycotics
    Miscellaneous:

     E25 Treatment received with any investigational agent within one month before this trial.
     E26 Female subject who is pregnant or lactating or with a positive pregnancy test
     E27 Topical cosmetic preparations are allowed on skin areas other than the test areas, but must not be changed during the study
     E28 Sunbathing and solarium use are not allowed during the study. If bathing and showering, the subject must apply the cream after bathing or showering to avoid washing off the cream. No additive products (bath oil, etc.) are allowed. Use of public swimming pools is not allowed during the study.
     Sunbathing and solarium use are not allowed during the study. Bathing and showering is allowed as long as no additive products (bath oil, etc.) are used. Use of public swimming pools is not allowed during the study.
     E29 Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s return for follow-up visits on schedule
     E-30 Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrolment
     E31 Subject is institutionalized because of legal or regulatory order
    E.5 End points
    E.5.1Primary end point(s)
    Exploratory Efficacy Endpoints:
    • Differences in change from Baseline to Days 8, 15, 22 and 29, 36 and 43 in erythema measured by chromametry between the treatments within each cohort separately
    • Difference in change from Baseline to Days 8, 15, 22, 29, 36 and 43 in ADSI between the treatments within each cohort separately
    • Differences in change from Baseline to Days 8, 15, 22 and 29, 36 and 43 in TEWL between treatments within each cohort separately

    Safety Endpoints:
    • Safety and tolerability as assessed by treatment emergent adverse events (AEs), concomitant medications, change from baseline in physical exam, vital signs, laboratory values
    •Difference in change from Baseline to Days 8, 15, 22, 29, 36 and 43 in skin thickness measured by ultrasound at between the treatments within each cohort separately

    PK Exploratory Analysis:
    • PK assessment of plasma levels at the Baseline Visit (prior to treatment), Day 22 and Day 43
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    single active ingredient nortriptyline
    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 concerned2
    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
    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 months
    E.8.9.1In the Member State concerned days91
    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) No
    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 Information not present in EudraCT
    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 Yes
    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 state60
    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 Decision2009-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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