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    Summary
    EudraCT Number:2011-006283-42
    Sponsor's Protocol Code Number:KAD166
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-006283-42
    A.3Full title of the trial
    Placebo-controlled double-blind trial investigating the efficacy and tolerability of Posterisan® akut with lidocaine (50 mg/g rectal ointment) in abatement of complaints associated with the anorectal symptom complex
    Placebokontrollierte Doppelblindstudie zum Nachweis der Wirksamkeit und Verträglichkeit von Posterisan® akut mit Lidocain (50 mg/g Rektalsalbe) in der Linderung von Beschwerden beim anorektalen Symptomenkomplex
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-controlled double-blind trial investigating the efficacy and tolerability of Posterisan® akut with lidocaine (50 mg/g rectal ointment) in abatement of complaints associated with the anorectal symptom complex
    Placebokontrollierte Doppelblindstudie zum Nachweis der Wirksamkeit und Verträglichkeit von Posterisan® akut mit Lidocain (50 mg/g Rektalsalbe) in der Linderung von Beschwerden beim anorektalen Symptomenkomplex
    A.4.1Sponsor's protocol code numberKAD166
    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 SponsorDr. Kade Pharmazeutische Fabrik GmbH
    B.1.3.4CountryGermany
    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 supportDr. Kade Pharmazeutische Fabrik GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Kade Pharmazeutische Fabrik GmbH
    B.5.2Functional name of contact pointClinical Research
    B.5.3 Address:
    B.5.3.1Street AddressRigistr. 2
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12277
    B.5.3.4CountryGermany
    B.5.4Telephone number493072072137
    B.5.5Fax number493072082250
    B.5.6E-mailmarijasuesskind@kade.de
    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 Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Kade Pharmazeutische Fabrik GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePosterisan® akut mit Lidocain 50 mg/g Rektalsalbe
    D.3.4Pharmaceutical form Rectal ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE
    D.3.9.1CAS number 137-58-6
    D.3.9.2Current sponsor coden.a.
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboRectal ointment
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relief of complaints associated with anorectal symptom complex (pain, burning, itching)
    Linderung von Beschwerden beim anorektalen Symptomenkomplex (Schmerzen, Brennen, Juckreiz)
    E.1.1.1Medical condition in easily understood language
    Relief of complaints associated with anorectal symptom complex (e.g. pain, burning, itching in the anal region)
    Linderung von Beschwerden beim anorektalen Symptomenkomplex (wie z.B. Schmerzen, Brennen, Juckreiz im Afterbereich)
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10002580
    E.1.2Term Anorectal therapeutic procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Proof of superior efficacy of Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe compared with placebo (vehicle without active substance) in the relief of symptoms associated with the anorectal symptom complex
    Nachweis einer überlegenen Wirksamkeit von Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe im Vergleich zu einer wirkstofffreien Salbengrundlage (Placebo) in der Linderung von Beschwerden beim anorektalen Symptomenkomplex
    E.2.2Secondary objectives of the trial
    Determining the local tolerability/safety of Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe in the relief of symptoms associated with the anorectal symptom complex
    Erfassung der lokalen Verträglichkeit/Unbedenklichkeit von Posterisan® akut mit Lidocain 50 mg/g Rektalsalbe in Linderung von Beschwerden beim anorektalen Symptomenkomplex
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - signed informed consent
    - adults ≥ 18 years
    - patients with the anorectal symptom complex (pain or burning or itching)
    - at least one of the symptoms from the anorectal symptom complex (pain, burning, itching) hast to be ≥ 65 on the visual analogue scale (VAS): Most bothersome symptom
    - Rechtsgültige Einverständniserklärung zur Studienteilnahme
    - Alter ≥ 18 Jahre
    - Patienten mit anorektalem Symptomenkomplex (Schmerz oder Brennen oder Juckreiz)
    - Mindestens ein Symptom des anorektalen Symptomenkomplexes (Schmerz, Brennen, Juckreiz) muss auf der visuellen Analogskala (VAS) ≥ 65 eingestuft sein: Leitsymptom
    E.4Principal exclusion criteria
    - Intra-anal or peri-anal thrombosis
    - hemorroides grade III and IV
    - known type IV hypersensitivity
    - rectal carcinoma (suspicion or assured diagnosis)
    - chronic inflammatory bowel diseases (Morbus Crohn, Colitis ulcerosa)
    - use of symptoms´ relieving medications (e.g. antihistamines, local anesthetics, analgetics), or in the context of any causal treatment, which could influence the symptoms pain, burning or itching, one week before screening
    - hypersensitivity against lidocaine or any other substance of the investigational product
    - known or suggested drug or alcohol abuse
    - pregnancy and lactation
    - participation on a clinical trial 12 weeks before screening
    - Committal to an institution due to an official or court order
    - Intraanale oder perianale Thrombosen
    - Hämorrhoiden Grad III und IV
    - Fissur
    - Bekannte Typ IV-Allergie
    - Rektumkarzinom (Verdacht oder gesichert)
    - Chronisch entzündliche Darmerkrankungen (M. Crohn, Colitis ulcerosa)
    - Einnahme/Anwendung von beschwerdelindernden Medikamenten (z. B. Antihistaminika, Lokalanästhetika, Analgetika) oder im Rahmen einer Kausaltherapie, die die Symptome Schmerz, Brennen oder Juckreiz beeinflussen könnte, eine Woche vor dem Studienbeginn
    - Überempfindlichkeit gegen Lidocain oder einen der sonstigen Bestandteile des Prüfpräparates
    - Bekannter oder vermuteter Drogen- oder Alkoholabusus
    - Schwangerschaft und Stillzeit
    - Teilnahme an einer klinischen Prüfung 12 Wochen vor dem Studienbeginn
    - Unterbringung aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt
    E.5 End points
    E.5.1Primary end point(s)
    Improvement (decrease) in the subjective most bothersome symptom (MBS) of the anorectal symptom complex: Difference VAS T0 - VAS T3
    Vergleich zwischen Verum und Placebo für die Besserung (Abnahme) des Leitsymptoms des anorektalen Symptomenkomplexes: Differenz VAS T0 - VAS T3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 3
    Tag 3
    E.5.2Secondary end point(s)
    - Comparison in the change between verum and placebo in the most bothersome symptom (MBS) an days 1 and 2 (Difference VAS T0 - VAS T1 or T2)
    - Change in the MBS on days 1, 2 and 3 in comparison to screening (T0)
    - Subgroup analysis: Improvement in the particular symptom (pain, burning, itching): Difference VAS T0 - VAS T3
    - Responders/Non-responders (responders: MBS on VAS < 30 mm)
    - Evaluation of tolerability by the physician
    - Evaluation of tolerability by the patient
    - Vergleich zwischen Verum und Placebo für die Besserung (Abnahme) des Leitsymptoms des anorektalen Symptomenkomplexes an den Tagen 1 und 2 (Differenzen: VAS T0 - VAS T1 bzw. 2)
    - Änderung der Zielvariablen (Leitsymptom) an den Tagen 1, 2, 3 der Anwendung im Vergleich zum Screening (T0)
    - Subgruppenanalyse: Besserung (Abnahme) der einzelnen Symptome (Schmerz, Brennen, Juckreiz): Differenz VAS T0 - VAS T3
    - Responder/Nonresponder (Responder: Leitsymptom auf VAS < 30 mm)
    - Beurteilung der Verträglichkeit durch den Arzt
    - Beurteilung der Verträglichkeit durch den Patienten
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 - 3 (depending on the sec. endpoint)
    Tag 1 - 3 (abhängig vom sek. Endpunkt)
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 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 concerned12
    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
    the last visit of the last subject undergoing the trial
    die letzte Visite des letzten Patienten
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    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 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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state200
    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)
    normal treatment of the condition
    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 Decision2012-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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