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    Summary
    EudraCT Number:2014-002625-35
    Sponsor's Protocol Code Number:PERIOC_CTP001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-11-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-002625-35
    A.3Full title of the trial
    The effect of locally delivered ciclosporin as an adjunct to healing after treatment of periodontal pockets
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial looking at how well locally applied ciclosporin can support the healing after non-surgical treatment of chronic periodontitis
    A.4.1Sponsor's protocol code numberPERIOC_CTP001
    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 SponsorPerioC Ltd
    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 supportPerioC Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSFL Regulatory Affairs & Scientific Communication Ltd
    B.5.2Functional name of contact pointBettina Barton
    B.5.3 Address:
    B.5.3.1Street AddressSchillerstrasse 7
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4053
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4161361 94 43
    B.5.5Fax number+4161361 94 42
    B.5.6E-mailoffice@sfl-services.com
    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 nameCiclosporin Nanosuspension Gel
    D.3.4Pharmaceutical form Periodontal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriodontal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number41.7
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe chronic periodontitis
    E.1.1.1Medical condition in easily understood language
    Moderate to severe chronic periodontitis
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    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 assess the effectiveness of a mucoadhesive thermosensitive formulation of ciclosporin, administered into gingival pockets of patients with chronic periodontal disease to reduce the inflammation and promote reattachment and healing, measured by probing pocket depth and frequency of bleeding on probing.
    E.2.2Secondary objectives of the trial
    The secondary objectives selected for this study are to assess the local anti-inflammatory effectiveness of the drug by measuring inflammatory biomarkers in gingival crevicular fluid, to assess progress of healing by measuring gains in clinical attachment level, and to assess the safety of the drug for this indication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of informed consent
    2) Patients must be at least 40 years of age and in good general health according to medical history and clinical judgment.
    3) Patients must have 2 pairs of contralateral interproximal periodontal sites with probing depths of at least 7mm in single-rooted teeth, not associated with furcations or root furrows. The test sites should have a distance of at least two teeth to the control sites.
    4) Teeth selected should have a vital pulp as determined by thermal or electric stimulation.
    5) Available for appointments and willingness to strictly adhere to re- examination schedule
    E.4Principal exclusion criteria
    1) Patients already included in other clinical trials involving therapeutic intervention (either medical or dental).
    2) Periodontal treatment during the last 6 months.
    3) Antibiotic treatment 6 months prior to the start of the trial.
    4) Antibiotic prophylaxis required for dental treatment.
    5) Patients with acute infectious lesions in the areas of intended treatment.
    6) Regular anti-inflammatory medication.
    7) Known history of ciclosporin allergy.
    8) Ongoing medication that may affect the clinical features of periodontitis. (e.g., antibiotics or immuno-modulatory/ immunosuppressive drugs such as dexamethasone, prednisone, tacrolimus)
    9) Patients who are smokers.
    10) Patients that are immuno-compromised or on immunosuppressive medication.
    11) Patients who are pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints selected are:
    1) Mean change in probing pocket depth from baseline to 3-month examination.
    2) Change in bleeding on probing (measured as present or absent) from baseline to 3-month examination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Baseline and 3-month examination
    2) Baseline and 3-month examination
    E.5.2Secondary end point(s)
    The secondary endpoints selected are:
    1) Frequency of periodontal pockets showing a probing pocket depth ≤ 4 mm and with no bleeding on probing at the 3-month examination.
    2) Changes in biomarker (tumour necrosis factor-α, matrix metalloproteinase-8, matrix metalloproteinase-13, prostaglandin E2 and cyclophilin A) concentrations: Baseline versus 3-day, 10-day and 3-month examination.
    3) Gain in clinical attachment level (CAL) in mm at 3-months examination time point relative to baseline.
    4) Safety evaluation (adverse events).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 3-month examination
    2) Baseline, 3-day, 10-day and 3-month examination
    3) Baseline and 3-month examination
    4) 3-day, 7-day, 10-day and 3-month examination
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Split-mouth design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard non-surgical treatment (mechanical debridement) alone
    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.8.5The 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 months
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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)
    After the 3-month examination period, each patient will be offered continuation of standard treatment as indicated. The non-surgical treatment protocol the patients have been subjected to does not deviate from standard clinical procedures in the non-surgical treatment phase of periodontal disease, except for the adjunctive treatment with Ciclosporin Nanosuspension Gel.
    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 Decision2014-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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