NCT00359905

Brief Summary

A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,228

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

August 2, 2006

Last Update Submit

February 18, 2009

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasiaalpha-blockers

Outcome Measures

Primary Outcomes (1)

  • Change in baseline total score on the International Prostate Symptom Score

    12 weeks

Secondary Outcomes (4)

  • Change in baseline obstructive subscore of the International Prostate Symptom Score;

    12 weeks

  • change in baseline irritative subscore of the International Prostate Symptom Score;

    12 weeks

  • change in baseline maximum urine flow rate;

    12 weeks

  • safety

    52 weeks

Study Arms (3)

Silodosin

EXPERIMENTAL
Drug: Silodosin

Tamsulosin

ACTIVE COMPARATOR
Drug: Tamsulosin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SilodosinDRUG

8 mg daily for 12 weeks

Also known as: KMD3213
Silodosin
TamsulosinDRUG

0.4 mg daily for 12 weeks

Also known as: Omnic
Tamsulosin
PlaceboDRUG

once daily for 12 weeks

Placebo

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

You may not qualify if:

  • Medical conditions that would confound the efficacy evaluation
  • Medical conditions in which it would be unsafe to use an alpha-blocker
  • Use of concomitant drugs that would confound the efficacy evaluation
  • Use of concomitant drugs that would be unsafe with this alpha-blocker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (2)

  • Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697-706. doi: 10.1007/s00345-015-1519-2. Epub 2015 Feb 25.

    PMID: 25712312DERIVED

  • Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernandez Fernandez E; European Silodosin Study Group. Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe. Eur Urol. 2011 Mar;59(3):342-52. doi: 10.1016/j.eururo.2010.10.046. Epub 2010 Nov 10.

    PMID: 21109344DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosinTamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Christopher Re Chapple, BSc MD

    Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2006

First Posted

August 3, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

January 1, 2008

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

GB(1)