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

Merck Sharp & Dohme LLC1,395 enrolled

Overview

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.

All participants received placebo (run-in) for 1 week prior to randomization to Parts 1 and 2. Participants who complete the base study may be screened for a year-long, multicenter extension for assessment of long-term safety and efficacy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,395

Conditions

Urinary Bladder, Overactive

Interventions

VibegronDRUG

Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning.

Tolterodine ERDRUG

Participants received one tolterodine ER 4 mg capsule, taken orally once a day.

Placebo matching vibegronDRUG

Participants received placebo matching vibegron tablets, taken orally each morning.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.

Time frame: Baseline and Week 8

Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

Time frame: Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.

Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE

Time frame: Part 1: up to 8 weeks; Part 2: up to 4 weeks

Extension Study: Number of Participants Who Experienced an Adverse Event (AE)

Time frame: Extension: up to 54 weeks (including 2-week follow-up)

Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE

Data from ClinicalTrials.gov

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Secondary Outcomes

Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.

Time frame: Baseline and Week 8

Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8

Time frame: Baseline and Week 8

Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8

Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.

Time frame: Baseline and Week 8

Extension Study: Change From Baseline in Average Daily Micturitions at Week 52

Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Time frame: Baseline and Week 52 of Extension Study

Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52

Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Time frame: Baseline and Week 52 of Extension Study

Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52

Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Time frame: Baseline and Week 52 of Extension Study

Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52

Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.

Time frame: Baseline and Week 52 of Extension Study