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    Summary
    EudraCT Number:2008-002208-24
    Sponsor's Protocol Code Number:A3051103
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-12
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-002208-24
    A.3Full title of the trial
    A FOUR WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,
    PARALLEL-GROUP, PHASE 2A STUDY OF VARENICLINE TARTRATE (CP-526,555) IN THE TREATMENT OF POST-HERPETIC NEURALGIA
    A.4.1Sponsor's protocol code numberA3051103
    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 SponsorPfizer Inc., 235 East 42nd Street,New York,NY 10017
    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.3.2Product code CP-526,555
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNVarenicline (as tartrate)
    D.3.9.1CAS number 375815-87-5
    D.3.9.2Current sponsor codeCP-526,555
    D.3.9.3Other descriptive name7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino(2,3-h)(3)benzazepine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 placeboFilm-coated tablet
    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
    POST-HERPETIC NEURALGIA
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.To evaluate the analgesic efficacy of varenicline versus placebo in patients with postherpetic neuralgia (PHN)

    2.To evaluate the safety and tolerability of varenicline versus placebo in patients with postherpetic neuralgia.

    3.To characterize the pharmacokinetics of varenicline in patients with post-herpetic neuralgia.
    E.2.2Secondary objectives of the trial
    no further objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

    1. Male or female, at least 18 years of age.

    Females – Non-childbearing Potential:
    Female subjects of non-childbearing potential must meet at least one of the following
    criteria:
    • Post menopausal females
    • Females who are surgically sterile, defined as having had a documented hysterectomy
    and/or bilateral oophorectomy

    Females – Childbearing Potential:
    • Defined as using adequate contraception consisting of 2 forms of birth control, one of
    which must be a barrier method, is not pregnant, lactating, and is not breastfeeding.
    Females of childbearing potential must have a negative serum pregnancy test at
    Baseline (V1).

    Male Contraception Guidelines:
    • Male patients must agree that female spouses/partners will use contraception as
    defined above or be of non-childbearing potential (post-menopausal or surgically
    sterile);

    2. Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN;

    3. Patients must have a score of greater than or equal to (≥) 4 for pain from PHN on the 11- point NRS pain scale administered in the clinic at the Baseline (V1) visit. Note that the
    baseline phase of the study will only begin after the required 2-week minimum washout
    period from all prohibited concomitant medications;

    4. Patients must have an average daily pain score greater than or equal to (≥) 4 and completed at least 4 daily pain diaries over the 7 days of the Baseline phase of the study (assessed at V2);


    5. Patients must be able to understand and cooperate with trial procedures, and have signed a written informed consent prior to entering the trial.
    E.4Principal exclusion criteria
    1.Patients who are tobacco users including cigarette smokers and users of non-cigarette tobacco products within 6 months prior to Baseline. Use of smoking cessation products including prescription medications such as buproprion and varenicline within 6 months prior to Baseline;

    2.Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN;

    3.Severe pain, which may impair the self-assessment of the pain due to
    PHN;

    4.Skin conditions in the affected dermatome that could alter sensation, other than PHN;

    5.Chronic hepatitis B or C, acute hepatitis B or C within the past 3 months;

    6.History of HIV infection;

    7.A history of alcohol or illicit drug abuse or dependency in the past 2 years. In addition, patients who fail a urine toxicology screen for illegal drugs;

    8.Active cancer, including suspected metastases, or treatment for cancer or remission from any cancer other than cutaneous basal cell or squamous cell carcinoma resolved by excision for less than 5 years prior to Baseline;

    9.History within the previous 6-months of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, (ventricular tachycardia, left ventricular failure), New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks);

    10.Presenting with:
    • Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy);
    • Any clinically significant active infection;

    11.A major surgical operation within 1 month of Baseline;

    12.Uncontrolled hypertension or a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 95 mm Hg at Baseline;

    13.Clinically significant abnormal 12-lead ECG at Baseline;

    14.Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments:
    • AST or ALT >1.5 x ULN
    • Total bilirubin >1.5 x ULN
    • Estimated serum creatinine clearance < 30 mL/min

    15.Use of any prohibited concomitant medications during the last 2 weeks of the Screening period prior to the start of Baseline

    16.Use of any investigational drug agent or device during this study or within 1 month, or 5 half lives, prior to Baseline whichever is longer;

    17.History of severe drug induced hypersensitivity (ie, anaphylaxis);

    18.Patients with moderate or severe depression or anxiety based on investigator judgment or major depressive/anxiety disorder as defined by DSM-IV diagnostic criteria or depression/anxiety sub-scale score 11 on the Hospital Anxiety and Depression Scale at Baseline;

    19.“Moderate” or “severe” scores on any of the items comprising the Behaviour Monitoring Aid at Baseline;

    20.Patients with active suicidal ideation or suicidal behaviour (including suicide attempt) within 2 years prior to Baseline as determined through the use of the C-SSRS (Columbia-Suicide Severity Rating Scale) or by the investigator’s clinical judgment at the Baseline or Randomization / Day 1 visits;

    21.History, diagnosis or signs and symptoms of clinically significant neurological disease, including, but not limited to:
    • Alzheimer’s disease or other types of dementia;

    22.Inability to comprehend, or unwillingness to follow, the study requirements

    23. Patients who do not agree to abstain from using tobacco products of any kind, smoking cessation products (eg, nicotine replacement therapy, buproprion) or marijuana during study participation;

    24.Patients who plan to donate blood or blood products during participation or within 30 days after the end of the study;

    25.A body mass index (BMI) less than 15 kg/m2 or greater than 39 kg/m2. No patient will be enrolled with a weight less than 100 pounds (45.5.kg);

    26.Demonstrated intolerance or hypersensitivity to, the active substance or to any of the excipients contained in the marketed product;

    27.A history of intolerance or hypersensitivity to acetaminophen (paracetamol) or any of its excipients or existence of a medical condition or use of any concomitant medication for which the use of acetaminophen (paracetamol) is contraindicated;

    28.Other severe acute or chronic medical or psychiatric condition or clinical laboratory abnormality that may increase the risk associated with study participation, or investigational product administration, or may interfere with the interpretation of study results.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from Baseline period (defined as the period starting on V1 (Day -7) up to and including Day -1 (the day before Day 1/Randomization) to Week 4 in the average weekly pain score using the 11-point NRS (Numeric Rating Scale) daily diary.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days21
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 74
    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 Decision2008-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-30
    P. End of Trial
    P.End of Trial StatusCompleted
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