UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030560
Receipt number R000034891
Scientific Title Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Date of disclosure of the study information 2017/12/25
Last modified on 2020/01/02 13:04:35

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Basic information

Public title

Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia

Acronym

Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia

Scientific Title

Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia

Scientific Title:Acronym

Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia

Region

Japan


Condition

Condition

Benign prostatic hyperplasia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of tadalafil monotherapy and its combination with mirabegron for storage symptoms with benign prostatic hyperplasia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overactive bladder symptom score (OABSS)

Key secondary outcomes

Number of night urination
International prostate symptom score
Overactive bladder-questionnaire (OAB-q)
Nocturia-quality of life (N-QOL)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A monotherapy group, which continuously received 5 mg tadalafil daily for 8 weeks.

Interventions/Control_2

An add-on group, which received 5mg tadalafil daily and 50 mg mirabegron daily for 4 weeks after 5 mg tadalafil daily for 4 weeks.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

The study included men with benign prostatic hyperplasia. Inclusion criteria are total OABSS 3 or greater with urinary urgency at least once per week, IPSS question 7 score 2 or greater and age 50 years or greater.

Key exclusion criteria

Study exclusion criteria are post-void residual urine volume greater than 100 ml, acute urinary retention, neurogenic bladder dysfunction, severe bladder diverticulum or urethral stricture, urinary tract malignant disease, previous intrapelvic irradiation, renal or hepatic impairment, severe cardiac disease, or considered unsuitable for the trial by doctors.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Honda

Organization

Department of Surgery, Tottori University Faculty of Medicine

Division name

Dvision of Urology

Zip code

6838504

Address

36-1 Nishicho, Yonago, Tottori, Japan

TEL

0859-38-6607

Email

honda@tottori-u.ac.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Honda

Organization

Department of Surgery, Tottori University Faculty of Medicine

Division name

Dvision of Urology

Zip code

6838504

Address

36-1 Nishicho, Yonago, Tottori, Japan

TEL

0859-38-6607

Homepage URL


Email

honda@tottori-u.ac.jp


Sponsor or person

Institute

Division of Urology, Department of Surgery, Tottori University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tottori University Faculty of Medicine Ethics Committee

Address

36-1 Nishicho, Yonago, Tottori, Japan

Tel

0859-33-1111

Email

me-rinshoukenkyu@ml.adm.tottori-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

鳥取大学医学部附属病院(鳥取県)、鳥取赤十字病院(鳥取県)、鳥取県立中央病院(鳥取県)、山陰労災病院(鳥取県)、米子医療センター(鳥取県)、済生会境港病院(鳥取県)、松江市立病院(島根県)、松江赤十字病院(島根県)、松江生協病院(島根県)、浜田医療センター(島根県)、津山第一病院(岡山県)、吉野三宅ステーションクリニック(鳥取県)、わたなべクリニック(鳥取県)、みはらクリニック(鳥取県)、山本泌尿器クリニック(鳥取県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2016 Year 08 Month 04 Day

Date of IRB

2016 Year 08 Month 04 Day

Anticipated trial start date

2016 Year 08 Month 22 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 25 Day

Last modified on

2020 Year 01 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034891


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name