UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003907
Receipt number R000004696
Scientific Title A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria.
Date of disclosure of the study information 2010/10/01
Last modified on 2010/11/08 20:27:06

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Basic information

Public title

A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria.

Acronym

A pilot study of generic Tamsulosin for benign prostatic hyperplasia patients with dysuria.

Scientific Title

A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria.

Scientific Title:Acronym

A pilot study of generic Tamsulosin for benign prostatic hyperplasia patients with dysuria.

Region

Japan


Condition

Condition

benign prostatic hyperplasia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To comfirm the efficacy of 4-week treatment by the generic Tamsulosin Hydrochloride for moderate benign prostatic hyperplasia patients with dysuria evaluated by international prostate symptom score (I-PSS) and QOL score.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

international prostate symptom score : I-PSS
QOL score

Key secondary outcomes

Uroflowmetry (if available at the study site)
Safety(vital, labo test, AEs)
Drug compliance


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Generic Tamsulosin Hydrochloride

Interventions/Control_2


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

90 years-old >=

Gender

Male

Key inclusion criteria

1)age >= 50 at IC
2)regularly visit will be possible during study period
3)I-PSS is from 8 to 19
4)prostate volume of >= 20mL
5)residual volume <= 150ml
6)written IC

Key exclusion criteria

1) Patients who treated by medicine that has androgenic hormone within 4 weeks before IC.
2) Patients with cases or suspicion of prostatic cancer
3) Patients with suspicion of neurogenic bladder
4) Patients with urethral stricture
5) Patients with chronic bacterial prostatitis or active urinary tract infection
6) Past history of surgery or invasive therapy for BPH.
7) Irradiation for pelvic area within 1 year prior to IC.
8) Patients with any disease that induce dysuria (such as bladder neck contracture or urolithiasis)
9) Patients with cardiovascular disease.
10) Patients with serious disease or impairment of liver, kidney and blood
11) patients who are participated in any clinical studies within 3 months prior to the study
12) Patients who are judged inappropriate for the clinical trial by the investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasunori Ishii

Organization

Ishii Clinic

Division name

Urology

Zip code


Address

Kitaurawa 4-3-8 Urawa-ku Saitama-shi, 330-0074 Saitama JAPAN

TEL

048-833-0010

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinji Tsukada

Organization

NPO MINS

Division name

Clinical trial supporting center

Zip code


Address

Shin Taiso Maruyama Building 2F 20-1 Maruyama-cho Shibuya-ku Tokyo,150-0044 JAPAN

TEL

03-6416-1868

Homepage URL


Email

support@clinic-irb.com


Sponsor or person

Institute

NPO MINS

Institute

Department

Personal name



Funding Source

Organization

ASKA Pharmaceutical

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization


Address


Tel


Email



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

石井クリニック(埼玉県)、くろおかクリニック(東京)、みずおクリニック(神奈川)、篠原Kクリニック(神奈川)


Other administrative information

Date of disclosure of the study information

2010 Year 10 Month 01 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

The I-PSS and the QOL score were significantly decreased after 4 weeks dosing of Restream&reg;. And the safety profile was similar to that of the original drug. These results confirmed that 4 weeks treatment by the generic drug of Tamsulosin Hydrochloride, Restream&reg;OD tablet, would be effective and be safety for BPH with moderate to severe dysuria.

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

Completed

Date of protocol fixation

2010 Year 07 Month 02 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2010 Year 10 Month 01 Day

Date of closure to data entry

2010 Year 10 Month 01 Day

Date trial data considered complete

2010 Year 11 Month 01 Day

Date analysis concluded

2010 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 07 Month 13 Day

Last modified on

2010 Year 11 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004696


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name