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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025282
Receipt No. R000029077
Scientific Title A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH)
Date of disclosure of the study information 2016/12/15
Last modified on 2019/02/05

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Basic information
Public title A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH)
Acronym CONTACT Study
Scientific Title A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH)
Scientific Title:Acronym CONTACT Study
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 add-on treatment of mirabegron (50mg/day) for OAB /BPH patients who were not satisfied with tadalafil (5mg/day) monotherapy for 8 weeks or longer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline to end of treatment in overactive bladder symptom score (OABSS) total score.
Key secondary outcomes 1) Changes in OABSS subscore (daytime frequency, night-time frequency, urgency, urgent incontinence).
2) Changes in international prostate symptom score (IPSS) total score and subscore (void, storage, postvoid, QOL).
3) Change in National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total score and subscore (pain, urination, QOL).
4) Changes in the parameters in frequency volume chart (number of void/ 24 hour, number of night-time void, number of urgency episodes/24 hour, number of incontinence episodes/24 hour).
5) Changes in postvoid residual (PVR) volume.
6) Changes in urine volume, Qmax and Qave.
7) Frequency of adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 Tadalafil monotherapy group: Group A
Tadalafil at the dose of 5mg is orally administered once daily after breakfast for 12 weeks.
Interventions/Control_2 Tadalafil/mirabegron combination therapy group: Group B
Tadalafil at the dose of 5mg and mirabegron at the dose of 50mg are orally administered once daily after breakfast for 12 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
90 years-old >
Gender Male
Key inclusion criteria 1) Male patients with BPH.
2) Patients who meet the following criteria even after administering tadalafil 5mg/day for more than 8 weeks:
OABSS total score >3
Urgency > once/week (OABSS urgency score >= 2)
3) Aged >=50 years and < 90 years
4) Patients who are able to give informed consent.
5) Patients from whom we have received written consent.
Key exclusion criteria 1) Patients with a history of hypersensitivity to tadalafil or mirabegron
2) Medication with anti-cholinergics, cholinergics,beta-agonists or antagonists, alpha-blocker and any other agents for treating pollakisuria/urinary incontinence during 8 weeks prior to the study. (Eligible if the medication was discontinued before tadalafil administration (before 8 weeks or more).5 alpha-reductase inhibitors or anti-androgen drugs can be included if they were administered > 6months and the patients had stable condition).
3) History or current condition of urinary retention or severe difficulty of urination
4) Patients with cancer in the part of lower urinary tract such as prostate or bladder, neurogenic bladder, urethra stricture, chronic bacterial prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis
5) Patients with serious cardiac disorder, serious cerebrovascular disease, serious liver dysfunction and serious kidney dysfunction
6) Qmax < 5 mL/sec
7) Postvoid residual volume (PVR) >150 mL
8) Any other patients who are regarded as unsuitable for this study by the investigator.
Target sample size 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Yamanishi
Organization Dokkyo Medical University
Division name Department of Urology and Neurology, Continence Center
Zip code
Address 880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
TEL 0282-86-1111
Email yamanish@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Yamanishi
Organization Dokkyo Medical University
Division name Department of Urology and Neurology, Continence Center
Zip code
Address 880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293, JAPAN
TEL 0282-86-1111
Homepage URL
Email yamanish@dokkyomed.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 15 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 Completed
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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