A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00379067

Enrollment

882

Registered

2006-09-21

Start date

2005-10-31

Completion date

2006-11-30

Last updated

2014-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia, Nocturia, Actigraphy, Tamsulosin

Brief summary

Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg & placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.

Interventions

DRUGTamsulosin OCAS

Adrenoceptor antagonist

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed as having LUTS associated with BPH * On average, at least 2 voids per night over the last week * 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)

Exclusion criteria

* Subject is currently taking diuretics * Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h

Design outcomes

Primary

Measure	Time frame
The change from baseline to week 12 in mean number of nocturnal voids	12 weeks

Secondary

Measure	Time frame
The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void	12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026