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
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
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
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
