SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN WITH SIMPLIFIED BLADDER TRAINING VERSUS SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN ALONE IN A PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, OVERACTIVE BLADDER SYMPTOM STUDY - SOLAR

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005546-39-HU
• Date of registration: 16/03/2006
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe BV
• Public title: SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN WITH SIMPLIFIED BLADDER TRAINING VERSUS SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN ALONE IN A PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, OVERACTIVE BLADDER SYMPTOM STUDY - SOLAR
• Scientific title: SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN WITH SIMPLIFIED BLADDER TRAINING VERSUS SOLIFENACIN SUCCINATE IN A FLEXIBLE DOSE REGIMEN ALONE IN A PROSPECTIVE, RANDOMIZED, PARALLEL GROUP, OVERACTIVE BLADDER SYMPTOM STUDY - SOLAR
• Date of first enrolment: 28/06/2006
• Target sample size: 706
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005546-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: yes Other specify the comparator: IMP plus bladder training

Countries of recruitment

Czech Republic, Finland, Hungary, Ireland, Italy, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
At study entry:
Male or female subject aged MT 18 years
Written informed consent has been obtained.
Subject is capable of completing the simplified bladder training regimen correctly.
Subject is willing and able to complete the micturition diary correctly.
Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for more than / equal to 3 months.
At randomization:
Subject must experience the following symptoms during the 3 day micturition diary period: At least 3 episodes of urge incontinence or at least 3 episodes of urgency.
Subject must experience frequency of micturition on average more than / equal to 8 times per 24-hour period during the 3-day micturition diary period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
At study entry:
Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing 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 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 (for female subjects confirmed by a cough provocation test).
Subject with a neurological cause for abnormal detrusor activity.
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.
Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated.
Non-drug treatment for OAB including electrostimulation therapy and pelvic floor exercises in the four weeks prior to the commencement of the study (or during the study apart from those included in the study bladder training instructions).
Subject who has received cognitive bladder training in the last 6 months.
Subject who intends to commence bladder training other than the study regimen during the study. (Any bladder training outside of the study regimen should be postponed until after the study).
Use of drugs intended to treat urinary incontinence, concomitant use of a strong CYP3A4 inhibitor, e.g. Ketoconazole (see appendix 1).
Myasthenia gravis or diabetic neuropathy
Known or suspected hypersensitivity to solifenacin succinate, other anticholinergics or lactose.
Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of severe renal (GFR 30 mL/min), or moderate, hepatic impairment, chronic intestinal disease, megacolon, bladder obstruction or chronic and severe constipation requiring treatment.
Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer.
Employees of the Astellas Group, third parties associated with the study, or the study site.
At randomization:
Subject who did not complete the micturition diary according to the instructions.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Solifenacin succinate is indicated for the relief of symptoms of urinary frequency, nocturia and urgency with or without incontinence, associated with overactive bladder 10059617

Intervention(s)

Trade Name: Veicare 5 mg film-coated tablet
Veicare 10 mg film-coated tablet
Product Name: Solifenacin succinate tablets
Product Code: YM905
Pharmaceutical Form: Tablet
INN or Proposed INN: solifenacin succinate
CAS Number: 242478-38-2
Current Sponsor code: YM905
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: solifenacin succinate
CAS Number: 242478-38-2
Current Sponsor code: YM905
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the efficacy of solifenacin succinate 5mg od plus simplified bladder training compared with solifenacin succinate 5mg od alone at 8 weeks in subjects with overactive bladder symptoms

Primary end point(s): Change from baseline in mean number of micturitions per 24 hours after 8 weeks

Secondary Objective: To assess the efficacy of a flexible dose regimen of solifenacin succinate 5mg or 10mg od plus simplified bladder training compared with a flexible dose regimen of solifenacin succinate 5mg or 10mg od alone at 16 weeks in subjects with overactive bladder symptoms. To compare subject perception of symptoms and treatment satisfaction. To compare the utility associated with quality of life for subjects with overactive bladder symptoms. To assess the safety and tolerability of solifenacin succinate in subjects with overactive bladder

Secondary ID(s)

905-EC-003

2005-005546-39-IE