Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Bladder, Overactive
Intervention: Solifenacin succinate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Central Contact, Study Chair, Affiliation: Astellas Pharma Europe B.V.
Summary
Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose
increase. Primary efficacy assessment of OAB symptoms by patient diaries.
Clinical Details
Official title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4
Secondary outcome: Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours Change from baseline in patient perception of bladder condition (PBC) Change from baseline in patient perception of urgency 'bother' (UB-VAS) Percentage of patients requiring an increase in the dose of the study medication Patient assessment of treatment satisfaction (TS-VAS)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is willing and able to complete the micturition diary correctly.
- Symptoms of overactive bladder (including urinary frequency, urgency with/without
urge incontinence) for >= 3 months
- At least 3 episodes of urgency with or without incontinence in last 3 days
- At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4)
during the 3-day micturition diary period
- Patient must experience frequency of micturition on average >= 8 times per 24-hour
period during the 3-day micturition diary period
Exclusion Criteria:
- Pregnant women or women who intend to become pregnant during the study or women of
childbearing potential who are sexually active and practising an unreliable method of
birth control or will be lactating during the study. Reliable contraceptive methods
are intra-uterine devices, contraceptive pills of combination type, hormonal implants
and injectable or patch contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the
predominant factor as determined by the investigator
- Patient with indwelling catheters or practising intermittent self-catheterisation
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as
interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous
or current malignant disease of the pelvic organs
- Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow
angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal
impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic
intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong
CYP3A4 inhibitor, e. g. ketoconazole
- Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor
exercises are permissible if established at least 4 weeks prior to study start and
intended to be continued throughout the study; electrostimulation therapy is not
permissible at any time
- Use of drugs intended to treat urinary incontinence
- Diabetic neuropathy
- Any clinically significant condition, which in the opinion of the investigator makes
the patient unsuitable for the trial
- Participation in any clinical trial within 30 days prior to randomisation
- Employees of the Yamanouchi Group, third parties associated with the study, or the
study site
- Patient who did not complete the micturition diary according to the instructions
Locations and Contacts
Antwerp, Belgium
Brugge, Belgium
Brussels, Belgium
Gent, Belgium
Hasselt, Belgium
Kortrijk, Belgium
Leuven, Belgium
Liege, Belgium
Ostrava, Czech Republic
Prague, Czech Republic
Zlin, Czech Republic
Mansoura, Egypt
Lille, France
Lomme, France
Mulhouse, France
Nantes, France
Nimes, France
Paris, France
Aichach, Germany
Bad Neuenaher, Germany
Bamberg, Germany
Bautzen, Germany
Berlin, Germany
Dierdorf, Germany
Duelmen, Germany
Dusseldorf, Germany
Frankfurt, Germany
Henningsdorf, Germany
Munich, Germany
Neustadt, Germany
Nurnberg, Germany
Planegg, Germany
Athens, Greece
Crete, Greece
Ioannina, Greece
Budapest, Hungary
Nyiregyhaza, Hungary
Pecs, Hungary
Szeged, Hungary
Tatabanya, Hungary
Bari, Italy
Catanzaro, Italy
Cinisello Balsamo, Italy
Magenta, Italy
Modena, Italy
Perugia, Italy
Turin, Italy
Udine, Italy
Bydgoszcz, Poland
Wroclaw, Poland
Abrantes, Portugal
Lisbon, Portugal
Porto, Portugal
Santarem, Portugal
Moscow, Russian Federation
Banska Bysterica, Slovakia
Martin, Slovakia
Zilina, Slovakia
Barcelona, Spain
Coana, Spain
Cordoba, Spain
Madrid, Spain
Merida, Spain
San Cristobal de la Laguna, Spain
Sevilla, Spain
Birmingham, United Kingdom
Cottingham, United Kingdom
Croydon, United Kingdom
Edinburgh, United Kingdom
Huntingdon, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Oldham, United Kingdom
Stoke on Trent, United Kingdom
Sunderland, United Kingdom
Torbay, United Kingdom
Welwyn Garden City, United Kingdom
Worthing, United Kingdom
Additional Information
Link to Results on JAPIC - enter 140585 in the JapicCTI-RNo. field
Related publications: Cardozo L, Hessdörfer E, Milani R, Arañó P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.
Starting date: April 2004
Last updated: September 17, 2014
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