Phase 2
Completed N=1,395
A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT01314872 ↗
Enrolled (actual)
1,395
Serious AEs
2.2%
Results posted
Jun 2016
Primary outcomePrimary: Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8 — -1.16; -1.62; -1.61; -1.80 Micturitions — p=0.056
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8 |
-1.16; -1.62; -1.61; -1.80; -2.07; -1.71 | 0.056 |
| PRIMARY Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE) |
66; 55; 70; 62; 70; 68 | — |
| PRIMARY Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE |
3; 3; 4; 2; 2; 4 | — |
| PRIMARY Extension Study: Number of Participants Who Experienced an Adverse Event (AE) |
134; 157; 158; 82 | — |
| PRIMARY Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE |
11; 14; 24; 7 | — |
| SECONDARY Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8 |
-1.24; -1.52; -1.81; -1.95; -1.95; -1.69 | 0.167 |
| SECONDARY Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8 |
-1.52; -1.71; -2.01; -2.13; -2.11; -1.86 | 0.401 |
| SECONDARY Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8 |
-1.59; -1.77; -2.27; -2.36; -2.83; -2.53 | 0.598 |
| SECONDARY Extension Study: Change From Baseline in Average Daily Micturitions at Week 52 |
-2.53; -2.77; -2.15; -3.25 | — |
| SECONDARY Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52 |
-2.43; -2.15; -2.23; -2.44 | — |
| SECONDARY Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52 |
-2.70; -2.42; -2.50; -2.48 | — |
| SECONDARY Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52 |
-3.11; -3.42; -2.94; -4.18 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01314872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.