A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia - RESTORE

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2005-001627-11-DK
• Date of registration: 30/08/2005
• Prospective Registration: Yes
• Primary sponsor: Yamanouchi Europe B.V. (to be renamed Astellas Pharma Europe B.V., as of August 2005)
• Public title: A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia - RESTORE
• Scientific title: A randomized, double-blind, placebo-controlled study to assess the effect of Tamsulosin OCAS 0.4 mg tablets, once daily on nocturia, compared to placebo, in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia - RESTORE
• Date of first enrolment: 27/10/2005
• Target sample size: 1051
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001627-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:

Countries of recruitment

Czech Republic, Denmark, Finland, Hungary, Ireland, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
At study entry (visit 1):
1. Male subject aged 45 years or over
2. Written informed consent has been obtained
3. Diagnosed as having LUTS associated with BPH
4. A total I-PSS score of greater than / equal to 13
5. A maximum urinary flow rate of greater than / equal to 4.0 mL/s and less than / equal to 12.0 mL/s, with a voided volume greater than / equal to 120 ml during free flow (a minimum of 2 flows are to be performed within 3 months of visit 1)
6. PSA levels are within normal ranges, or if outside of normal ranges are not of clinical significance according to the investigator. A recent PSA value (determined within 3 months of visit 1) is acceptable. If a recent value is not available, a blood sample should be taken at visit 1 to determine PSA levels.
7. On average, at least 2 voids per night over the last week
8. A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

At randomization (visit 2):
9. A total I-PSS score of greater than / equal to 13
10. Compliance to run-in medication has been at least 80%
11. Based on the sleep diary given to subject at the screening visit, on average at least 2 voids per night over 3 consecutive days (Monday-Thursday) before visit 2

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 (visit 1):
1. Previous surgery to the bladder neck, prostate or pelvic region (including thermo-therapies)
2. Previous pelvic radiation for any cause
3. A post-voiding residual volume >250 ml by ultrasound or catheterization in at least two assessments over the last 3 months
4. A known history or diagnosis or any of the following urinary conditions:
a) Neurological bladder disorder (including disorders due to diabetic neuropathy)
b) Bladder neck stenosis
c) Stone in bladder or urethra
d) Recurrent urinary tract infection (defined as at least two UTIs within the last 6 months)
e) Bladder cancer (including polyposis)
f) Prostate cancer
g) Urethral stricture
h) Other condition which may affect micturition (such as large bladder diverticulae)
5. A symptomatic urinary tract infection within 1 month prior to visit 1
6. Subject has nocturnal polyuria (defined as >33% of 24 h urine produced between 11p.m. and 7 a.m.) as determined by a 3-day frequency/volume chart completed between visit 1 and visit 2
7. Known hepatic or renal insufficiency
8. Alcohol consumption of more than 15 units per week (1 unit = 270 ml of beer or 40 ml of spirits or 125 ml of wine)
9. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to visit 1, such as myocardial infarction, uncontrolled angina, significant ventricular arrthymias, heart failure (NYHA class III/IV), orthostatic hypotension or stroke.
10. Central nervous system conditions, such as senile dementia, multiple sclerosis, Parkinson’s Disease and psychiatric disorders.
11. Known life-threatening diseases, such as concurrent neoplasms under treatment, AIDS/HIV
12. Hypersensitivity to the study drug (alpha-AR-antagonists) or any of their components.
13. Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study
14. Subject is currently taking 5alpha-reductase inhibitors or took these within the last 3 months prior to visit 1
15. Subject is currently taking any diuretics
16. Subject is currently taking other pharmacological treatment for BPH, such as alpha-AR-antagonists (including tamsulosin) and plant extracts, or took these within the last month prior to visit 1
17. Subject is currently taking other drugs which may influence the pharmacodynamic effects of tamsulosin, such as combined alpha / beta-AR-antagonists, alpha-agonists, cholinergics or anti-cholinergics
18. Subject is currently taking other investigational drugs, or took part in a clinical study within the last 3 months prior to visit 1, or took part in more than 3 clinical studies within 12 months prior to visit 1
19. Subject is unwilling or unlikely to fulfill the study requirements in terms of visits, compliance and time commitment
20. Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
21. Employees of the sponsor, CRO or investigator site involved in the study.



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

LUTS (lower urinary tract symptoms) associated with BPH (benign prostatic hyperplasia)

Intervention(s)

Trade Name: Omnic OCAS, prolonged release tablets (film-coated) 0.4 mg
Product Name: Tamsulosin OCAS, TOCAS
Pharmaceutical Form: Prolonged-release tablet
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the effect of Tamsulosin OCAS 0.4 mg o.d. compared to placebo on improvement of nocturnal voiding frequency, in subjects with LUTS associated with BPH over 12 weeks.

Primary end point(s): The change from baseline to week 12 in mean number of nocturnal voids measured using the sleep diary.

Secondary Objective: To assess the effect of Tamsulosin OCAS 0.4 mg o.d. compared to placebo, on improvement in hours of undisturbed sleep (HUS), defined as the duration of the first period of undisturbed sleep, in subjects with LUTS associated with BPH over 12 weeks.

To compare the secondary efficacy variables and the safety/tolerability of Tamsulosin OCAS 0.4 mg and placebo.

Secondary ID(s)

2005-001627-11-IE

617-EC-006