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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-002421-37
    Sponsor's Protocol Code Number:A4291043
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2008-002421-37
    A.3Full title of the trial
    A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
    A.4.1Sponsor's protocol code numberA4291043
    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., Ramsgate Road, Sandwich, Kent, CT13 9NJ, 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.3.1Product namePD 0299685
    D.3.4Pharmaceutical form Capsule, hard
    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 313651-33-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 namePD 0299685
    D.3.4Pharmaceutical form Capsule, hard
    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 313651-33-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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, hard
    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
    INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008927
    E.1.2Term Chronic interstitial cystitis
    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 efficacy of PD 0299685 in the treatment of symptoms associated with
    interstitial cystitis/painful bladder syndrome including bladder pain, urinary urgency and frequency.

    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of PD 0299685.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Visit 1. The following inclusion criteria have to be met in order for a subject to be randomized into this trial:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Male and female subjects aged ≥18 years.
    3. Diagnosis of IC/PBS
    4. Evidence of cystoscopy within 2 years of screening to confirm the absence of other significant lower urinary tract pathology and the presence or absence of cystoscopic features of IC (eg glomerulations, Hunner’s ulcer).
    Note: Cystoscopy is mandated within 2 years of enrollment. Subjects who have not had cystoscopy within 2 years of screening may undergo the procedure at screening. However placebo run-in would need to be deferred according to the type of cystoscopy performed.
    Subjects undergoing general anesthetic cystoscopy may be included at the discretion of the Pfizer study clinician, and any such case should be discussed prior to their enrollment.
    5. Moderate to severe IC/PBS at screening (Visit 1) as defined by PUF and ICSI total scores:
    • PUF total score ≥13 with a score of 2 or greater on question 5 (pain)
    • ICSI total score ≥7
    6. Female subjects must be non-pregnant and non-lactating, and be either, postmenopausal, surgically sterilized, or using an appropriate method of contraception. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (Visit 1). See Section 5.4 for further details.
    7. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other trial-related activities.
    Visit 2. The following continuation criteria have to be met in order for subjects to be randomized:
    8. Completes at least 4 daily pain scores during the 7 days prior to randomization with a mean daily worst pain severity score of ≥4 (0-10 NRS); the mean severity score is defined as the average of all 24 hr worst pain severity scores recorded in the 7 days prior to randomization.
    9. Mean micturition frequency per 24 hours ≥8 as derived from the symptom diary completed prior to Visit 2.
    E.4Principal exclusion criteria
    1. Symptoms of IC ≤6 months prior to Screening
    2. Post-void residual volume >200 mL at Screening
    3. Mean voided volume <50 mL or > 350 mL
    4. Total volume voided >3000 mL per 24 hours
    5. Greater than 1+ hematuria on dipstick at Screening, unless fully investigated prior to randomization. Subjects who are menstruating may be re-screened once menstruation has ceased
    6. Proven UTI at Screening or randomization
    7. Medical history at Screening
    •Any history of: Genitourinary tuberculosis, high grade/stage bladder cancer of any histological type, urethral cancer, prostate cancer; recurrent urinary tract infection defined as ≥ 2 UTIs in past 6 months or ≥ 3 in 1 year; lower urinary tract anatomical anomaly, urethral and/or bladder obstruction; pelvic radiotherapy.
    •≤5 years Low grade/stage TCC
    •History within prior 3 months of: Bacterial prostatitis; urethritis; active genital herpes.
    •≤ 6 weeks Bacterial cystitis
    •Current history of: Proven genitourinary infection, symptomatic urinary tract stone.
    8. Subjects who have undergone the following procedures:
    •Any history of: Augmentation cystoplasty, cystectomy or cystolysis, neurectomy
    •≤6 months prior to screening: Urogenital surgery such as hysterectomy, urethral sling procedure, urinary incontinence surgery, trans-vaginal surgery, prolapse surgery, vaginal delivery or cesarean section, prostate surgery or treatment, other bladder or urethral surgery which could interfere with bladder function.
    •≤3 months prior to screening: Formal therapeutic urethral dilatation or urethrotomy
    •≤6 weeks prior to screening: Cystoscopy under general anesthetic,
    Hydrodistention, laser or electrofulguration of Hunner’s ulcer, prostate biopsy.
    •≤2 weeks Cystoscopy under local anesthetic, bladder biopsy, urodynamics (cystometrogram)
    9. The following conditions at Screening: Indwelling urinary catheters or who perform Intermittent Self Catheterization, Passive urinary incontinence, Incapable of independent toileting
    10. Subjects at Screening who intend to start bladder training program, electrostimulation/neuromodulation, acupuncture, or physiotherapy during the study Subjects who are on an established regimen for ≥3 months prior to Screening may remain on this as long as it remains unchanged for the duration of the study
    11. Subjects taking the following treatments for their interstitial cystitis at Screening as noted below:
    •Prior 6 months: Intravesical Botulinum toxin A or BCG
    •Prior 3 months: Biologic agents
    •Prior 1 month: Other intravesical treatments not otherwise specified, including butnot limited to dimethylsulfoxide, pentosan polysulphate, sodium hyaluronate,heparin, chondroitin sulfate, lidocaine or bupivicaine.
    •Prior 2 weeks: Oral gabapentin or pregabalin
    12. Receipt of any investigational drug within 30 days (or 5 times the plasma half life, whichever is longer) preceding the Screening visit, or during the course of the study. Subjects who have received tanezumab in a previous study should wait at least 147 days from dosing until randomization in this study
    13. History of allergic or hypersensitivity reaction to gabapentin, pregabalin, or PD 0299685 or ingredients of the formulations
    14. Estimated Glomerular Filtration Rate (eGFR by Cockcroft-Gault) ≤60 mL/min at Screening
    15. Clinically significant abnormal ECG at Screening including QTcF >500 msec
    16. Clinically significant abnormalities on Screening laboratory tests
    17. Suicide Behaviors Questionnaire – Revised score ≥8 at screening
    18. Patient Health Questionnaire – 9 total score ≥15 or a score ≥1 on question 9
    19. Subjects who answer “yes” on either question 1 or 2 of the Suicide Ideation section or “yes” to any of the 6 questions in the Suicidal Behavior section of the Columbia-Suicide Severity Rating Scale at Screening or Randomization, otherwise determined a significant current risk for suicidal or violent behavior
    20. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder associated with hospital admission or suicide attempt within the last 5 years
    21. Subjects who intend to donate blood during the study or within 30 days after last scheduled study visit
    22. History of malignancy within the past 2 years except basal cell carcinoma curatively treated
    23. Drugs of abuse on urine drug screen, unless arising from medication that is medically indicated or prescribed by a physician
    24. Alcohol or drug abuse within the past 2 years
    25. Significant, uncontrolled acute or chronic disease which would increase the risk associated with study participation or would make the patient inappropriate for entry into this study
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 12 in the worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
    Change from baseline to Week 12 in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
    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 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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 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
    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
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days24
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 129
    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 Decision2008-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-19
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