A Phase IIb Clinical Study of the Efficacy and Satefy of MK-4618 in Patients with Overactive Bladder

• Register: KCT
• Last refreshed on: 27 May 2013
• Main ID: KCT0000316
• Date of registration: 09/01/2012
• Primary sponsor: MSD Korea LTD
• Public title: A Phase IIb Clinical Study of the Efficacy and Satefy of MK-4618 in Patients with Overactive Bladder
• Scientific title: A Phase IIb Randomized, Placebo- and Active Comparator (Tolterodine)-Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder
• Date of first enrolment: 2011-06-16
• Target sample size: 41
• Recruitment status: Recruiting
• URL: http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1730
• Study type: Interventional Study
• Study design: Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Caregiver, Allocation : RCT

Countries of recruitment

Korea, Republic of

Contacts

• Name: Myung-Soo Choo
• Affiliation: Asan Medical Center

• Name: Myung-Soo Choo
• Affiliation: Asan Medical Center

Key inclusion & exclusion criteria

Inclusion criteria: -If female, must be of non-childbearing potential
-If male of reproductive potential, must agree to remain abstinent or use (or have his partner use) 2 acceptable methods of birth control within the projected duration of the study
-Has a clinical history of OAB for at least 3 months and meets either the OAB wet or OAB dry criteria
-Is able to read, understand and complete questionnaires and voiding diaries by herself/himself
-Is ambulatory and in good general physical and mental health
-Has no clinically significant electrocardiogram or laboratory abnormality
Exclusion criteria: -Has evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia
-Has an allergy, intolerance, or has a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or MK-4618 formulation; or has a history or active diagnosis of any condition contraindicated in the tolterodine ER prescribing label
-Has lower urinary tract pathology that could be responsible for urgency, frequency, or incontinence
-Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply
-Has a history of continual urine leakage
-Has had surgery to correct stress urinary incontinence or prolapsed uterus within 6 months
-Has a known history of elevated postvoid residual
-Has undergone bladder training or electrostimulation within 2 weeks or plans to initiate either during the study
-Has active or recurrent (>6 episodes per year) urinary tract infections
-Has hematuria
-Has a requirement for an indwelling catheter or intermittent catheterization
-Has a history of fecal incontinence

Age minimum: 40(Year)
Age maximum: 75(Year)
Gender: Both

Health Condition(s) or Problem(s) studied

Diseases of The genitoruinary system

Intervention(s)

Drug : [Part I]
At Visit 3, patients meeting eligibility requirements will be randomized to the doubleblind treatment period (1:1:1:1:1:1:1) to receive MK-4618 3 mg, 15 mg, 50 mg, or 100 mg, tolterodine ER 4 mg, MK-4618 50 mg + tolterodine ER 4 mg (4 weeks)/MK-4618 50 mg (4 weeks), or placebo once daily. There is a single placebo matching the image of the MK-4618 3 mg, 15 mg, and 50 mg tablets, referred to below in Table 2-1 as placebo matching MK-4618.
[part II]
At Visit 3, patients meeting eligibility requirements will be randomized to the doubleblind treatment period (2:2:2:1) to receive MK-4618 X mg, tolterodine ER 4 mg, MK-4618 X mg + tolterodine ER 4 mg dosed concomitantly, or placebo as shown in Table 2-2 below. Patients will be stratified by the IRT system according to whether the
patient met OAB wet or OAB dry criteria.
If the MK-4618 1 mg treatment arm is added to Part 2, patients will be randomized in a 2:2:2:2:1 ratio.

Primary Outcome(s)

To assess the safety and tolerability of treatment with the selected MK-4618 doses either alone or dosed concomitantly with tolterodine ER

To investigate a dose-related reduction in average number of daily micturitions compared with placebo at Week 8

Secondary Outcome(s)

The effect of concomitant dosing (MK-4618 and tolterodine ER) compared with the effect of the selected dose of MK-4618 monotherapy and of tolterodine ER monotherapy on the number of daily micturition

To assess the effect of MK-4618 compared with placebo on: the average number of urge incontinence in OAB wet, the average number of total incontinence in OAB wet, the average number of strong urge

To investigate whether there is a lower incidence of dry mouth when treated with MK-4618 compared with tolterodine ER

Secondary ID(s)

NCT01314872

Secondary Sponsor(s)

MSD Korea LTD