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    Summary
    EudraCT Number:2007-005781-12
    Sponsor's Protocol Code Number:A6631013
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2007-005781-12
    A.3Full title of the trial
    A FOUR WEEK, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2A STUDY OF PH-797804 IN THE TREATMENT OF POST-HERPETIC NEURALGIA
    A.4.1Sponsor's protocol code numberA6631013
    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 Limited, Ramsgate Road, Sandwich, Kent UK
    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 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 PH-797804
    D.3.4Pharmaceutical form Capsule*
    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.3.9.1CAS number 586414-48-4
    D.3.9.2Current sponsor codePH-797804
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboCapsule*
    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 (PHN)
    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
    • To evaluate the efficacy of PH-797804 in patients with post-herpetic neuralgia.
    • To evaluate the safety and tolerability of PH-797804 in patients with post-herpetic neuralgia.
    • To collect blood samples for pharmacokinetic analysis of PH-797804 in patients with post-herpetic neuralgia.
    E.2.2Secondary objectives of the trial
    Not Applicable
    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
    2. Females must be of non-childbearing potential. Females of non-child-bearing potential will be defined as:
    • Females with a documented hysterectomy and/or bilateral oophrectomy, or
    • Females have been amenorrheic for at least 2 years and have a serum FSH level >30 IU/L in the absence of hormone replacement therapy
    3. 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.
    4. Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).
    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 have undergone neurolytic or neurosurgical therapy including skin excisions for post-herpetic neuralgia
    2. Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
    3. History of chronic hepatitis B or C within the past 3 months, or HIV infection
    4. Patients who have a history of alcohol or illicit drug abuse in the past 2 years.
    5. History of cancer (other than cutaneous basal cell) in the previous 5 years.
    6. History within the previous year 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).
    7. Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Deriviative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG). Refer to Section 7.2.4 for additional clarification.
    8. A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold test™) where used. Refer to Section 7.2.4 for additional clarification
    9. History within the previous 6 months of:
    • An epileptic seizure.
    • Poorly controlled Type 1 or Type 2 diabetes.
    • Acute hepatitis of any aetiology.
    10. Presenting with:
    • Any condition possibly affecting oral drug absorption (e.g. gastrectomy or clinically significant diabetic gastroenteropathy);
    • Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0;
    • Any clinically significant active infection
    • Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV;
    11. A major surgical operation within 1 month of screening.
    12. ECG abnormalities at screening or randomization, including those listed below. The investigator will decide whether ECG abnormalities other than those listed are clinically significant and should exclude the subject from enrolment if abnormality is considered to be clinically significant:
    • Subjects with pre-randomization evidence of QTc prolongation at screening (V1) or at V2 (defined as >450 ms) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings and is made by the investigator at the time of ECG collection.
    • Predominant heart rhythm other than normal sinus rhythm e.g. atrial fibrillation, atrial flutter, supraventricular tachycardia.
    • Atrioventricular (AV) block greater than first degree.
    • Resting heart rate >100 or <40 bpm.
    • Evidence of previous myocardial infarction in the absence of clinical history consistent with these findings.
    • Evidence of acute ischaemia.
    13. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments:
    • Hgb <10 g/dL, Hct <32%;
    • Absolute WBC count <3.0 x 109/L (<3000/mm3)
    • Neutrophil count < 1.2 x 109/L (<1200/mm3)
    • Platelet count <100 x 109/L (<100,000/mm3)
    • AST or ALT >1.2 x ULN
    • Total bilirubin >1.2 x ULN
    • Alkaline phosphatase >1.2 x ULN
    • Albumin <3.5 g/dL or 35 g/L due to known liver disease
    • Serum creatinine >ULN
    14. Use of any of the prohibited concomitant medications within the time frame prior to the start of screening or during the run-in period.
    15. Use of any investigational drug within 1 month, or 5 half lives, prior to screening whichever is longer.
    16. History of severe drug induced hypersensitivity (i.e anaphylaxis)
    17. Patients with severe depression based on investigator judgment or major depressive disorder as defined by DSM-IV diagnostic criteria or depression sub-scale score >10 on the Hospital Anxiety and Depression Scale.
    18. Patients judged to be a serious suicidal risk.
    19. Inability to comprehend, or unwillingness to follow, the study requirements including attendance at out-patient clinic visits and participation in laboratory testing as called for by the protocol.
    20. Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Daily Pain Rating Scale (11-point Numeric Rating Scale)
    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 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 80
    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 Decision2008-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-05
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