Overactive BladderPhase 1NCT01500382
A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)
A Phase 1 study testing Vibegron, Tolterodine ER and Prophylactic Antibiotic in people with Overactive Bladder and Overactive Urinary Bladder, run by Merck Sharp & Dohme LLC.
Trial summary
The study is designed to investigate the effects of the investigational drug vibegron (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive bladder. The study will also evaluate the safety and tolerability of multiple oral doses of vibegron in women with overactive bladder. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Overactive Bladder, Overactive Urinary Bladder
- What is being tested?
- Vibegron, Tolterodine ER and Prophylactic Antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2012to 2 Jan 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-child bearing potential (status post menopausal or post hysterectomy,oophorectomy or tubal ligation). If of reproductive potential, must be non-pregnant (confirmed via blood test) and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug,throughout the study (including washout intervals between treatment periods/panels) and until at least 2 weeks after administration of the last dose of study drug in the last treatment period.
- Body mass index (BMI) of ≤40 kg/m^2 (ie, not morbidly obese)
- Clinical history of overactive bladder symptoms (OAB) for at least 3 months
- Capable of completing an accurate daily diary for reporting purposes
Who cannot join
- Mentally or legally incapacitated, such as significant emotional problems (other than situational depression) or diagnosed with a significant psychiatric disorder during the past 5-10 years
- Other types of urinary incontinence (ie,stress or mixed)
- History (current or past)of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain or Stage III or greater pelvic organ prolapse
- Other types of kidney/urinary bladder disease/obstruction or infection. Participants with with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator
- Inability to control bowel movements
- History of narrow angle glaucoma, immunocompromise, stroke, chronic seizures, major neurological disorders and/or other serious and chronic organ-system health conditions (ie, heart disease)
Show all 15Show fewer
- Urinary catheter, either permanent or intermittent placement
- Failure to meet medication profile requirements or directives required for study eligibility
- Condition for which there is a warning, contraindication, or precaution against the use of tolterodine ER or anticipates the use of prescription medications contraindicated with the use of tolterodine ER
- Daily alcohol or caffeine intake exceeds study requirements (for alcohol: defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day; and for caffeine: defined as greater than 3 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee,tea, cola, or other caffeinated beverages (ie, Red Bull) per day
- Inability to refrain from smoking throughout the study's duration
- Illicit drug use
- Recent surgery or recent participation in another clinical trial
- Severe, frequent allergies or history of life-threatening reactions or intolerability to prescription or non prescription medications or food
- Intended or unintended extended absence or exposure to significant change in time zone or sleep schedule (ie, transmeridian travel or shift work) that will interfere with accurate completion of scheduled daily diary entries
About this study
Official title: A Placebo and Active-Comparator Controlled Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of MK-4618 in Patients With Overactive Bladder
The study is designed to investigate the effects of the investigational drug vibegron (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive bladder. The study will also evaluate the safety and tolerability of multiple oral doses of vibegron in women with overactive bladder. Overactive bladder is best described as urgency and frequency of urination, with or without involuntary urination and/or the need to awaken during the night to urinate.
The primary efficacy hypothesis is that vibegron is superior to placebo with respect to change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e., steady state) in participants with overactive bladder. A true mean increase (vibegron/placebo) of 25% in bladder volume is expected.
The primary safety hypothesis is that administration of multiple oral doses of vibegron is sufficiently well-tolerated in participants with overactive bladder, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.
Read the detailed description
Participants will be randomized in each of 2 treatment periods to 1 of 4 possible treatments, which will be administered in double-dummy fashion, and participants will undergo urodynamic procedures prior to dosing on Day 1 and after 7 days of treatment.
- Conditions
- Overactive Bladder, Overactive Urinary Bladder
- Being tested
- Vibegron, Tolterodine ER, Placebo (vibegron), Placebo (tolterodine ER), Prophylactic Antibiotic
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibegronDrug
Also called MK-4618
Tablet, 50 or 100 mg, once daily, for up to 10 days based on treatment assignments and treatment period.
Tolterodine ERDrug
Also called Detrol LA™
Capsule, 4 mg, once daily, for up to 10 days based on treatment assignment and treatment period.
Placebo (vibegron)Other
Inactive agent in tablet form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period.
Placebo (tolterodine ER)Other
Inactive agent in capsule form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period.
Prophylactic AntibioticDrug
Also called Levaquin, Biocef, Ed A-Ceph, Keflex
A pre-procedural prophylactic antibiotic (ie, levofloxacin 250 mg, cephalexin) administered orally, 30 minutes prior to each scheduled urodynamic study intervention. It is up to the discretion of the Investigator, based on study protocol recommendations, as to which type of antibiotic may be administered.
| Study group | Role | What they receive |
|---|---|---|
| Vibegron 100 mg + tolterodine ER 4 mg → placebo | Experimental | During Treatment Period 1, participants will receive 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Receives: Drug: Vibegron; Drug: Tolterodine ER; Other: Placebo (vibegron); Other: Placebo (tolterodine ER); Drug: Prophylactic Antibiotic |
| Placebo → vibegron 100 mg | Experimental | During Treatment Period 1, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER. Receives: Drug: Vibegron; Other: Placebo (vibegron); Other: Placebo (tolterodine ER); Drug: Prophylactic Antibiotic |
| Placebo → tolterodine ER 4 mg | Active comparator | During Treatment Period 1, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily tolterodine 4 mg and placebo to match vibegron. Receives: Drug: Tolterodine ER; Other: Placebo (vibegron); Other: Placebo (tolterodine ER); Drug: Prophylactic Antibiotic |
| Placebo → vibegron 50 mg | Experimental | During Treatment Period 1, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER. Receives: Drug: Vibegron; Other: Placebo (vibegron); Other: Placebo (tolterodine ER); Drug: Prophylactic Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7
Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.
Measured: Baseline (pre-dose Day 1) and Day 7 (post-dose)
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Measured: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
Number of Participants Who Discontinued Use of Study Drug Due to an AE
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.
Measured: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
Secondary outcomes (1)
Fold-change From Baseline in Volume of Urine at First Desire to Void Post-dose on Day 7
Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.
Measured: Baseline (pre-dose Day 1) and Day 7 (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start27 Feb 2012
- Primary completion2 Jan 2013
- Study completion2 Jan 2013
Why it stopped: This study was terminated early due to insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500382
- Sponsor's protocol ID
- 4618-004
- Status last verified
- Dec 2018
- First submitted
- 22 Dec 2011
- Last updated
- 24 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo and Active-Comparator Controlled Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of MK-4618 in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT01500382
- Acronym / sponsor ID
- 4618-004
- Conditions
- Overactive Bladder, Overactive Urinary Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to insufficient recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2012 (actual)
- Primary completion
- 2 Jan 2013 (actual)
- Study completion
- 2 Jan 2013 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Posted 26 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to investigate the effects of the investigational drug vibegron (MK-4618) compared to placebo on maximum urinary bladder capacity in women with overactive bladder. The study will also evaluate the safety and tolerability of multiple oral doses of vibegron in women with overactive bladder. Overactive bladder is best described as urgency and frequency of urination, with or without involuntary urination and/or the need to awaken during the night to urinate.
The primary efficacy hypothesis is that vibegron is superior to placebo with respect to change from baseline in maximum cystometric capacity at 2 hours postdose on Day 7 (i.e., steady state) in participants with overactive bladder. A true mean increase (vibegron/placebo) of 25% in bladder volume is expected.
The primary safety hypothesis is that administration of multiple oral doses of vibegron is sufficiently well-tolerated in participants with overactive bladder, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.
Detailed description
Participants will be randomized in each of 2 treatment periods to 1 of 4 possible treatments, which will be administered in double-dummy fashion, and participants will undergo urodynamic procedures prior to dosing on Day 1 and after 7 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vibegron 100 mg + tolterodine ER 4 mg → placebo | Experimental | Drug: Vibegron, Drug: Tolterodine ER, Other: Placebo (vibegron), Other: Placebo (tolterodine ER), Drug: Prophylactic AntibioticDuring Treatment Period 1, participants will receive 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. |
| Placebo → vibegron 100 mg | Experimental | Drug: Vibegron, Other: Placebo (vibegron), Other: Placebo (tolterodine ER), Drug: Prophylactic AntibioticDuring Treatment Period 1, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER. |
| Placebo → tolterodine ER 4 mg | Active comparator | Drug: Tolterodine ER, Other: Placebo (vibegron), Other: Placebo (tolterodine ER), Drug: Prophylactic AntibioticDuring Treatment Period 1, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily tolterodine 4 mg and placebo to match vibegron. |
| Placebo → vibegron 50 mg | Experimental | Drug: Vibegron, Other: Placebo (vibegron), Other: Placebo (tolterodine ER), Drug: Prophylactic AntibioticDuring Treatment Period 1, participants will receive 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants will then complete a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants will receive 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-child bearing potential (status post menopausal or post hysterectomy,oophorectomy or tubal ligation). If of reproductive potential, must be non-pregnant (confirmed via blood test) and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug,throughout the study (including washout intervals between treatment periods/panels) and until at least 2 weeks after administration of the last dose of study drug in the last treatment period.
- Body mass index (BMI) of ≤40 kg/m^2 (ie, not morbidly obese)
- Clinical history of overactive bladder symptoms (OAB) for at least 3 months
- Capable of completing an accurate daily diary for reporting purposes
Key exclusion criteria (15 listed)
- Mentally or legally incapacitated, such as significant emotional problems (other than situational depression) or diagnosed with a significant psychiatric disorder during the past 5-10 years
- Other types of urinary incontinence (ie,stress or mixed)
- History (current or past)of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain or Stage III or greater pelvic organ prolapse
- Other types of kidney/urinary bladder disease/obstruction or infection. Participants with with a history of uncomplicated kidney stones may be enrolled in the study at the discretion of the investigator
- Inability to control bowel movements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibegronAlso: MK-4618Tablet, 50 or 100 mg, once daily, for up to 10 days based on treatment assignments and treatment period. | Drug | Placebo → vibegron 100 mg, Placebo → vibegron 50 mg, Vibegron 100 mg + tolterodine ER 4 mg → placebo |
| Tolterodine ERAlso: Detrol LA™Capsule, 4 mg, once daily, for up to 10 days based on treatment assignment and treatment period. | Drug | Placebo → tolterodine ER 4 mg, Vibegron 100 mg + tolterodine ER 4 mg → placebo |
| Placebo (vibegron)Inactive agent in tablet form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period. | Other | Placebo → tolterodine ER 4 mg, Placebo → vibegron 100 mg, Placebo → vibegron 50 mg, Vibegron 100 mg + tolterodine ER 4 mg → placebo |
| Placebo (tolterodine ER)Inactive agent in capsule form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period. | Other | Placebo → tolterodine ER 4 mg, Placebo → vibegron 100 mg, Placebo → vibegron 50 mg, Vibegron 100 mg + tolterodine ER 4 mg → placebo |
| Prophylactic AntibioticAlso: Levaquin, Biocef, Ed A-Ceph, KeflexA pre-procedural prophylactic antibiotic (ie, levofloxacin 250 mg, cephalexin) administered orally, 30 minutes prior to each scheduled urodynamic study intervention. It is up to the discretion of the Investigator, based on study protocol recommendations, as to which type of antibiotic may be administered. | Drug | Placebo → tolterodine ER 4 mg, Placebo → vibegron 100 mg, Placebo → vibegron 50 mg, Vibegron 100 mg + tolterodine ER 4 mg → placebo |
Primary outcome
Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7
Time frame: Baseline (pre-dose Day 1) and Day 7 (post-dose)
Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Number of Participants Who Discontinued Use of Study Drug Due to an AE
Time frame: Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.
1 secondary outcome
Fold-change From Baseline in Volume of Urine at First Desire to Void Post-dose on Day 7
Time frame: Baseline (pre-dose Day 1) and Day 7 (post-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vibegron, Tolterodine ER and Prophylactic Antibiotic in people with Overactive Bladder and Overactive Urinary Bladder, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7 (time frame: Baseline (pre-dose Day 1) and Day 7 (post-dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.