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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-005431-97
    Sponsor's Protocol Code Number:B3P104833
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-02
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2005-005431-97
    A.3Full title of the trial
    An Eight-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Dose Ranging Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 250mg, 125mg, and 50mg administered Twice Daily vs Placebo, in Women with Overactive Bladder
    A.4.1Sponsor's protocol code numberB3P104833
    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 SponsorGlaxoSmithKline Research & Development
    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 Information not present in EudraCT
    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 nameSolabegron tablets
    D.3.2Product code GW427353
    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 INNSolabegron
    D.3.9.1CAS number 451470-34-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameSolabegron tablets
    D.3.2Product code GW427353
    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 INNSolabegron
    D.3.9.1CAS number 451470-34-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboTablet
    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
    Overactive bladder (OAB)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the efficacy of solabegron 250mg, 125mg, and 50mg administered twice daily to that of placebo in female subjects with OAB including symptoms of urgency with urge incontinence and frequency which may be associated with nocturia, but without bladder related pain.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of solabegron 250mg, 125mg, and 50mg administered twice daily compared to that of placebo in female subjects with OAB including symptoms of urgency with urge incontinence and frequency which may be associated with nocturia, but without bladder related pain.
    To characterize the pharmacokinetic relationship of solabegron (GW427353B) and its primary metabolite (GW678953X) in female subjects with OAB including symptoms of urgency with urge incontinence and frequency which may be associated with nocturia, but without bladder related pain.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Females with OAB who are >18 years but not older than 80 years of age who have signed the informed consent.
    • If of non-childbearing potential (i.e. physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]) or
    • If of childbearing potential, has had a negative pregnancy test at screen (serum) and at Day 1 (urine) and
    • Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
    • Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or
    • Uses hormonal contraceptives (oral, depots, patches, etc.) with double-barrier methods of contraception as outlined above, or
    • Abstains from sexual intercourse, or
    • Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy
    2. Female subjects with a BMI in the range ≥ 19 kg/m2 but <31 kg/m2.
    3. Subjects must have a pre-dose mean systolic/diastolic blood pressure reading of <= 140/90 mmHg before randomization can occur.
    4. While participating in the one or two week treatment-free run-in periods and three days immediately prior to randomization, Day 0 (Visit 2), subjects must also meet all of the following criteria as recorded in their electronic micturition diaries:
    • Mean of ≥ 10 micturitions/24 hrs over the three day diary recording period (micturitions are “toilet voids”. Incontinence episodes not associated with micturitions episodes are not considered micturition episodes)
    • Mean of ≥ 1 incontinence episode/24 hrs over the three day diary recording period
    • Mean of ≥ 1 urgency episode/24 hrs over the three day diary recording period
    • Mean volume voided of  250 mL/micturition reported over the three day diary recording period
    • Mean total urine volume of <3000 mL/24 hrs reported over the three day diary recording period
    E.4Principal exclusion criteria
    1. Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history
    2. Grade III/IV prolapse with cystocele or second or third degree uterine prolapse
    3. History of interstitial cystitis or bladder related pain
    4. History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening
    5. Subjects with urinary incontinence due to causes other than detrusor over activity (e.g., overflow incontinence or intrinsic sphincter deficiency)
    6. Nocturnal enuresis only
    7. Urinary retention, or other evidence of poor detrusor function
    8. Subjects with concurrent, recent (within 30 days), chronic or recurrent (> 4/year) urinary tract infections or bladder stones.
    9. Documented history of myocardial infarction, unstable angina, and/or has undergone coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty (PTCA) in the past year
    10. Congestive heart failure (New York Heart Association Class III or IV heart failure)
    11. Any concurrent condition or any clinically significant abnormality on the screening physical examination, laboratory tests, electrocardiogram (including ischemic heart disease), Hepatitis B or C, which, in the opinion of the Investigator, may affect the interpretation of efficacy or safety data, or which otherwise contraindicates participation in a clinical trial with a new chemical entity
    12. Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
    13. Subjects with neuropathology that could affect the lower urinary tract or nerve supply, including but not limited to multiple sclerosis, stroke, Parkinsonism, or spinal cord injury
    14. Subjects with diabetes insipidus
    15. Subjects with a fasting plasma glucose (FPG) >180 mg/dL at Day 0 (Visit 2)
    16. Clinically significant or unstable, endocrine, hepatic, renal, immunologic, or lung disease (i.e., glomerulonephritis, AIDS, asthma), or malignancy other than nonmelanomatous skin cancer
    17. History of diagnosed gastrointestinal obstructive disorders
    18. Chronic severe constipation
    Concomitant Medications
    19. Is currently taking any of the following medications:
    • Monoamine oxidase inhibitors
    • Systemic corticosteroids (Note: topical hydrocortisone and inhaled corticosteroids are allowed)
    • Warfarin or digoxin
    • Antiretroviral drugs
    • Inhaled beta agonists
    • Norepinephrine or dopamine reuptake inhibitors
    • Bile acid sequestrant, such as cholestyramine or colestipol
    • Herbal preparations. However, subjects who have been on a stable dose of these preparations prior to entering the study may continue to take these drugs. No new herbal preparations may be introduced or dosage changes initiated while participating in the study.
    • Anti-arrhythmics
    20. Subjects who have not been stable on anti-depressants, diuretics or alpha blockers for less than a month or not stable on SSRIs for 2 months.

    Abnormal Values of Concern
    21. Systolic BP >140 mmHg, diastolic BP >90 mmHg, or HR > 100 beats/minute at screening. If subject is receiving anti-hypertensive medication, then their BP must have been stable over the last month on the same dose of antihypertensives including, but not limited to, ACE inhibitors, diuretics, Ca channel blockers, or ß blockers
    22. Post-void residual urine volume >150mL documented on either of two bladder scans at screening
    23. QTc interval >450 msec at screening or Day 0, Visit 2
    24. Significant renal impairment as defined by the Cockroft-Gault equation* of (CLcr<50 mL/min) at screening and at Day 0 (Visit 2)
    * CrCl=(140-age/serum Cr) x (weight in kgs/72) x 0.85 [mL/min]
    25. Documented history of advanced hepato-biliary disease and/or an alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) that is > 2.5 times the upper limit of the reference range at screening and at Day 0 (Visit 2)
    26. Total bilirubin level >1.5 times the upper limit of the reference range at screening and at Day 0 (Visit 2)
    27. Lactate dehydrogenase (LDH) value >2.0 times upper limit of normal at screening and at Day 0 (Visit 2)
    28. History of prior anti-incontinence surgery
    29. History of radiation cystitis or history of pelvic irradiation
    E.5 End points
    E.5.1Primary end point(s)
    The percentage change from baseline to week 8 in the number of incontinence episodes per 24 hours. Subjects who get worse by more than 100% will be censored at 100% worsening. The last available post-baseline assessment on or before week 8 will be used in the calculation.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 256
    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)
    Patient will resume treatment they were on prior to the start of the clinical trial.
    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 Decision2006-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
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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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