UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007108
Receipt number R000008359
Scientific Title Anti-Muscarinic Agents Alone and in Combination With a Muscarinic Agonist in Subjects with Overactive Bladder(OAB) Symptoms
Date of disclosure of the study information 2012/01/31
Last modified on 2012/07/20 16:35:11

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Basic information

Public title

Anti-Muscarinic Agents Alone and in Combination With a Muscarinic Agonist in Subjects with Overactive Bladder(OAB) Symptoms

Acronym

Anti-Muscarinic Agents Alone and in Combination With a Muscarinic Agonist in Subjects with Overactive Bladder(OAB) Symptoms

Scientific Title

Anti-Muscarinic Agents Alone and in Combination With a Muscarinic Agonist in Subjects with Overactive Bladder(OAB) Symptoms

Scientific Title:Acronym

Anti-Muscarinic Agents Alone and in Combination With a Muscarinic Agonist in Subjects with Overactive Bladder(OAB) Symptoms

Region

Japan


Condition

Condition

Overactive Bladder

Classification by specialty

Urology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Determine Whether the Addition of Pilocarpine Interfaces with the Efficacy/Tolerability of Anti-Muscarinic Agents

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Compare change from baseline with 2weeks and 4weeks in the average number of micturitions per 24 hours
Compare change from baseline with 2weeks and 4weeks inthe average number of incontinence episodes per 24 hours
Compare change from baseline with 2weeks and 4weeks in dry mouth symptomatology (visual analog scale)

Key secondary outcomes

Adverse events will be used to assess tolerability of the combination.


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

Subjects who are maintained on either VESIcare (5 mg once daily), Uritos (0.1 mg twice daily), or BUP-4 (20 mg once daily) will be enrolled in this evaluation. After being treated with anti-muscarinic therapy alone for approximately 8 weeks, then continue treatment with the same daily dose of anti-muscarinic therapy and the appropriate dose of pilocarpine will be added for 4 weeks.

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Female

Key inclusion criteria

1)Females 20-80 years
2)Subjects with a history of OAB who are currently taking one of the following products 1.VESIcare (5 mg once daily), 2.Uritos(0.1 mg twice daily), or 3.BUP-4 (20 mg once daily)for at least 8 weeks (OD formulation of these products are not allowed for at least last 4 weeks)
3)Subjects who do not display overt symptoms of OAB.At baseline the following criteria must be met:
oUrinary frequency <13 micturitions per day, as recorded in the subject diary with or without symptoms of urgency (i.e., sudden desire to micturate)
oHistory of urge or mixed urinary incontinence with predominant urge incontinence
oMaximum of one urge incontinence episode per day over a 3-day period
4)Symptoms of OAB for 3 or more months
5)Dry Mouth Questionnaire Q1, VAS>=25
6)Able and willing to correctly and independently complete the subject urinary diaries for 3 days
7)Ability to use bathroom without assistance
8)Females of childbearing potential must have had a negative pregnancy test at the time of enrollment. They should not be breast-feeding, and not at an appreciable risk of becoming pregnant. All pre-menopausal subjects must be using a highly effective method of birth control during the study and for at least one month following the last dose of study medication. (Menopause defined as at least one year without menses.) A negative pregnancy test must be documented prior to treatment. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or a vasectomized partner.

Key exclusion criteria

1)stress incontinence, insensate incontinence and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator
2)history of neurogenic bladder
3)uninvestigated hematuria
4)acute urinary tract infections during the anti-muscarinic baseline period or recurrent UTI defined as receiving treatment for symptomatic UTI more than 2 times in the past year
5)indwelling catheter or requiring intermittent catheterization
6)bladder or lower urinary tract surgeries performed within the past 6 months, or those who had surgeries leading to complications such as fistula
7)diagnosed with bladder cancer, interstitial cystitis, or painful bladder syndrome within the past 6 months
8)taking diuretics or estrogen therapy that was not part of a long-term stable program of at least 6 months
9)severe renal impairment (CLCR<30mL/min)
10)taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin
11)severe hepatic impairment
12)employing bladder retraining/bladder drill programs
13)Subjects who were anticipated to begin or change other bladder therapies (non-medicinal) such as biofeedback or kegels, during the course of the study
14)Subjects with malignancy within the past 6 months or prior pelvic malignancies requiring radiation therapy or whose surgery had led to complications such as fistulas, etc
15)diagnosed Sjogrens syndrome
16)History of tachyarrhythmias or cardiac disease
17)Any medications that may interfere with the subject's suitability and/or effective participation in the study
18)history or current untreated narrow angle glaucoma
19)history of myasthenia gravis
20)the known or suspected biliary tract disease, nephrolithiasis, cognitive or psychiatric disturbances
21)hypersensitivity toward Solifenacin or pilocarpine or to any excipient in their respective formulations
22)participating in another clinical trial or receiving a non-approved drug less than 30 days prior to screening

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yataro Yamanaka

Organization

Nihon University Itabashi Hospital

Division name

Urology

Zip code


Address

30-1 Kami-cho Oyaguchi Itabashi-ku Tokyo 173-8610, Japan

TEL

03-3972-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Chikako Takeda

Organization

PPCJ corporation

Division name

Clinical Research Division

Zip code


Address

YabanaBldg 3rd FL 5-16-2 Shiba

TEL

03-5765-7733

Homepage URL


Email

chikako.takeda@ppcj.co.jp


Sponsor or person

Institute

Department of Urology, Nihon University Itabashi Hospital

Institute

Department

Personal name



Funding Source

Organization

TheraVida Inc.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

U.S.A


Other related organizations

Co-sponsor

PPCJ corporation

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

日本大学医学部附属板橋病院(東京都)Nihon University Itabashi Hospital(Tokyo)、ノガキクリニック(東京都)Nogaki Clinic(Tokyo)、林皮フ・泌尿器・内科クリニック(東京都)Hayashi Dermatology, Urology and Internal Medicine Clinic(Tokyo)、弓削医院(東京都)Yuge Clinic(Tokyo)、弁財泌尿器科・内科クリニック(埼玉県)Benzai Urology and Internal Medicine Clinic(Saitama)


Other administrative information

Date of disclosure of the study information

2012 Year 01 Month 31 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

2011 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2012 Year 06 Month 30 Day

Date of closure to data entry

2012 Year 06 Month 30 Day

Date trial data considered complete

2012 Year 06 Month 30 Day

Date analysis concluded

2012 Year 07 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 01 Month 20 Day

Last modified on

2012 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008359


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name