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

January 16, 2019 updated by: Merck Sharp & Dohme LLC

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 A 52-week Extension to: 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

1395

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Part 1: placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Experimental: Part 1: vibegron 3 mg
Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Experimental: Part 1: vibegron 15 mg
Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Experimental: Part 1: vibegron 50 mg
Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Experimental: Part 1: vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Active Comparator: Part 1: tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Tolterodine ER
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Other Names:
  • Detrol®
Experimental: Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg
Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Drug: Tolterodine ER
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Other Names:
  • Detrol®
Placebo Comparator: Part 2: placebo
Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Experimental: Part 2: vibegron 100 mg
Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Active Comparator: Part 2: tolterodine ER 4 mg
Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Tolterodine ER
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Other Names:
  • Detrol®
Experimental: Part 2: vibegron 100 mg + tolterodine ER 4 mg
Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Drug: Tolterodine ER
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Other Names:
  • Detrol®
Experimental: Extension Study: vibegron 50 mg
Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Experimental: Extension Study: vibegron 100 mg
Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
Drug: Placebo matching tolterodine ER
Participants received placebo matching tolterodine ER capsule, taken orally each morning.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Experimental: Extension Study: tolterodine ER 4 mg
Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
Drug: Placebo matching vibegron
Participants received placebo matching vibegron tablets, taken orally each morning.
Drug: Tolterodine ER
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Other Names:
  • Detrol®
Experimental: Extension Study: vibegron 100 mg + tolterodine ER 4 mg
Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
Drug: Vibegron
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.
Other Names:
  • MK-4618
Drug: Tolterodine ER
Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
Other Names:
  • Detrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8
Time Frame: Baseline and 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.
Baseline and Week 8
Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)
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.
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.
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
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.
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)
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.
Extension: up to 54 weeks (including 2-week follow-up)
Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE
Time Frame: Extension: up to 52 weeks
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.
Extension: up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8
Time Frame: Baseline and 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.
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
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.
Baseline and Week 8
Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8
Time Frame: Baseline and 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.
Baseline and Week 8
Extension Study: Change From Baseline in Average Daily Micturitions at Week 52
Time Frame: Baseline and Week 52 of Extension Study
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.
Baseline and Week 52 of Extension Study
Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52
Time Frame: Baseline and Week 52 of Extension Study
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.
Baseline and Week 52 of Extension Study
Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52
Time Frame: Baseline and Week 52 of Extension Study
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.
Baseline and Week 52 of Extension Study
Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52
Time Frame: Baseline and Week 52 of Extension Study
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.
Baseline and Week 52 of Extension Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2011

Primary Completion (Actual)

October 22, 2012

Study Completion (Actual)

October 10, 2013

Study Registration Dates

First Submitted

March 11, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4618-008
  • 132241 (Registry Identifier: JAPIC-CTI)
  • 2010-022121-15 (EudraCT Number)
  • 2011-002533-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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