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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007108
Receipt No. 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

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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
Institute Department of Urology, Nihon University Itabashi Hospital
Institute
Department

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
URL(English) https://upload.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


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