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    The EU Clinical Trials Register currently displays   39194   clinical trials with a EudraCT protocol, of which   6422   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-001343-55
    Sponsor's Protocol Code Number:A6061030
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-001343-55
    A.3Full title of the trial
    A PHASE 2B LONG-TERM, RANDOMIZED, OPEN-LABEL, SAFETY AND TOLERABILITY TRIAL COMPARING [S,S]-REBOXETINE (PNU-165442G) WITH ROUTINE CARE IN PATIENTS WITH POSTHERPETIC NEURALGIA (PHN).
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA6061030
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 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 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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    D.3.4Pharmaceutical form 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 INN(+)-[S,S]-Reboxetine Succinate
    D.3.9.2Current sponsor codePNU-165442G
    D.3.9.3Other descriptive name[S,S]-RBX, (2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl]morpholine succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    D.3.4Pharmaceutical form 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 INN(+)-[S,S]-Reboxetine Succinate
    D.3.9.2Current sponsor codePNU-165442G
    D.3.9.3Other descriptive name[S,S]-RBX, (2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl]morpholine succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 3
    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 name[S,S]-Reboxetine Succinate
    D.3.2Product code PNU-165442G
    D.3.4Pharmaceutical form 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 INN(+)-[S,S]-Reboxetine Succinate
    D.3.9.2Current sponsor codePNU-165442G
    D.3.9.3Other descriptive name[S,S]-RBX, (2S)-2-[(S)-(2-ethoxyphenoxy) phenylmethyl]morpholine succinate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postherpetic neuralgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029223
    E.1.2Term 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 assess the long-term safety and tolerability of [S,S]-RBX in patients with PHN.
    E.2.2Secondary objectives of the trial
    To assess the effect of long-term treatment with [S,S]-RBX on neuropathic pain and health-related quality of life in patients with PHN.

    To assess the effect of long-term treatment with [S,S]-RBX on the use of pain-related medications for the management of PHN.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CLINICAL PHARMACOGENOMICS SUPPLEMENT - Final Protocol 9 March 2006
    The primary objective of this additional research component is to allow for the collection, storage, and use of samples to investigate possible associations between genetic variation in relation to response to [S,S]-Reboxetine and in relation to characteristics of postherpetic neuralgia and related conditions. For example, samples may be used to investigate possible associations between variants in the SLC6A2 gene, encoding the norepinephrine transporter (NET), or genes in the serotonin pathway (e.g. 5HT2A, 5HT2C & 5HTT) and response to [S,S]-Reboxetine. Scientific information about these differences among groups of subjects can help researchers to better understand the response of subjects to investigational drugs
    such as [S,S]-Reboxetine and to learn more about conditions such as postherpetic neuralgia.
    The secondary objective is to collect, store, and use the samples as controls in genetic investigations of the causes, natural history, and other aspects of important diseases and conditions for which Pfizer is researching new or improved drug therapies.
    This research may assist in the discovery of new or improved drug therapies.
    E.3Principal inclusion criteria
    · Male or female of any race at least 18 years of age.
    · Female patients must be postmenopausal, or surgically sterilized, or (if they are of childbearing potential) they must be nonpregnant and nonlactating and must be using appropriate methods of contraception (including barrier or hormonal method). Women of childbearing potential must have a confirmed negative urine pregnancy test at the screening visit (V1) and at the randomization visit (V2).
    · 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.
    · Patients at V1 must have a score ≥40 mm on the Pain Visual Analogue Scale (VAS).
    · Normal chest x-ray within 1 year prior to V1; or stable x-ray defined as no clinically significant change from previous exam (if none available, x-ray must be taken at V1).
    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
    · Malignancy within the past 2 years with the exception of basal cell carcinoma.
    · Patients with significant hepatic impairment (i.e. AST/ALT>2x ULN, Total bilirubin >2 x ULN)
    · Clinically significant abnormal 12-lead ECG (in the opinion of the investigator).
    · Neurological disorders unrelated to PHN that may confuse the assessment of neuropathic pain.
    · Any pain or other condition that may confound assessment or self-evaluation of the pain due to PHN.
    · History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection.
    · Skin conditions in the area affected by the neuropathy that (in the opinion of the investigator) could alter sensation.
    · Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN.
    · Amputations other than toes.
    · Administration of any investigational drug and/or agent within 30 days prior to screening.
    · Use of prohibited medications, in the absence of appropriate washout phases.
    · Abuse of drugs or alcohol within the last 2 years.
    · Any serious or unstable medical conditions that, in the opinion of the investigator, would compromise participation in the trial.
    · Any history of, or current, significant psychiatric disorder e.g. any DSM-IV Axis I or II Disorder or patients judged clinically to be a serious suicidal risk.
    · History of recurrent syncope or hypotension (systolic <90mmHg, diastolic <40mmHg).
    · Postural hypotension (a fall of 20mmHg in systolic BP or 10mmHg in diastolic BP on standing).
    · History of transient ischemic attack or stroke.
    · Carotid bruit, unless significant carotid stenosis (e.g. >70%) has been excluded by appropriate investigation.
    · History of uncontrolled narrow angle glaucoma.
    · History of epilepsy or seizure disorder.
    · Previous exposure to reboxetine.
    · History of urinary retention or prostatic hypertrophy (unless surgically corrected e.g. by TURP).
    · History of heart failure (NYHA class ≥2), myocardial infarction or unstable angina.
    E.5 End points
    E.5.1Primary end point(s)
    · Vital signs
    · Physical examination
    · 12-lead ECG
    · Hematology/Biochemistry
    · Adverse events
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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
    Comparator treatment arm consisting of routine care optimized on an individual basis
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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 years3
    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 years3
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-09-19. Yes
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 283
    F.4.2.2In the whole clinical trial 600
    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)
    As expected normal treatment
    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 Decision2006-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-10-15
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