A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)

• Status: Completed
• Trial end date: 2013-10-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a 2-part study to assess if vibegron (MK-4618) reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB). The primary hypothesis of the base study is that administration of vibegron demonstrates a dose-related reduction, compared with placebo, in average number of daily micturitions in participants with OAB after 8 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Tolterodine Tartrate

Criteria

Inclusion Criteria:

• If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study

• 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 without assistance

• Is ambulatory and in good general physical and mental health

• No clinically significant electrocardiogram or laboratory abnormality

Exclusion Criteria:

• If female, is currently pregnant or breast-feeding, or expecting to conceive within the projected duration of the study

• Evidence of diabetes insipidus, uncontrolled hyperglycemia or uncontrolled hypercalcemia

• Allergy, intolerance, or history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of tolterodine ER or vibegron (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

• History of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) that could affect the lower urinary tract or its nerve supply

• History of continual urine leakage

• Surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months

• Known history of elevated postvoid residual

• Bladder training or electrostimulation within 2 weeks or is planning to initiate either procedure during the study

• Active or recurrent (>6 episodes per year) urinary tract infections

• Current hematuria

• Required use of an indwelling catheter or requires intermittent catheterization

• History of fecal incontinence