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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

Page last updated: August 23, 2015

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