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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tamsulosin OCAS
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, Nocturia, Actigraphy, Tamsulosin

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Tamsulosin OCAS tablet

    Placebo tablet

    Outcomes

    Primary Outcome Measures

    The change from baseline to week 12 in mean number of nocturnal voids

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 19, 2006
    Last Updated
    October 8, 2014
    Sponsor
    Astellas Pharma Inc
    Collaborators
    Astellas Pharma Europe Ltd., Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00379067
    Brief Title
    A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Astellas Pharma Inc
    Collaborators
    Astellas Pharma Europe Ltd., Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia
    Keywords
    Benign Prostatic Hyperplasia, Nocturia, Actigraphy, Tamsulosin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    882 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Tamsulosin OCAS tablet
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin OCAS
    Intervention Description
    Adrenoceptor antagonist
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    The change from baseline to week 12 in mean number of nocturnal voids
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    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
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Use Central Contact
    Organizational Affiliation
    Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
    Description
    Link to Results on JAPIC - enter 140530 in the JapicCTI-RNo. field

    Learn more about this trial

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

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