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This study was terminated early due to insufficient recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibegron | Drug | Tablet, 50 or 100 mg, once daily, for up to 10 days based on treatment assignments and treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vibegron 100 mg + Tolterodine 4 mg → Placebo | During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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| 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. |
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| Tolterodine ER | Drug | Capsule, 4 mg, once daily, for up to 10 days based on treatment assignment and treatment period. |
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| Placebo (vibegron) | Other | Inactive agent in tablet form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period. |
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| 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. |
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| Prophylactic Antibiotic | Drug | 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. |
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|
| Baseline (pre-dose Day 1) and Day 7 (post-dose) |
| FG001 | Placebo → Vibegron 100 mg | During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER. |
| FG002 | Placebo → Tolterodine 4 mg | During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron. |
| FG003 | Placebo → Vibegron 50 mg | During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER. |
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| NOT COMPLETED |
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| Washout Period |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vibegron 100 mg + Tolterodine 4 mg → Placebo | During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. |
| BG001 | Placebo → Vibegron 100 mg | During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER. |
| BG002 | Placebo → Tolterodine 4 mg | During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron. |
| BG003 | Placebo → Vibegron 50 mg | During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed. | Posted | Baseline (pre-dose Day 1) and Day 7 (post-dose) |
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| Secondary | 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. | Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed. | Posted | Baseline (pre-dose Day 1) and Day 7 (post-dose) |
| |||||||||||||||||||||||||||||
| Primary | 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. | The All Subjects as Treated (AST) population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence. | Posted | Number | Participants | Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2) |
| |||||||||||||||||||||||||||
| Primary | 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. | The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence. | Posted | Number | Participants | Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2) |
|
Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)
The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vibegron 100 mg | Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg. | 0 | 1 | 0 | 1 | ||
| EG001 | Vibegron 100 mg + Tolterodine ER 4 mg | Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg. | 0 | 1 | 0 | 1 | ||
| EG002 | Vibegron 50 mg | Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg. | 0 | 1 | 0 | 1 | ||
| EG003 | Placebo | Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg. | 0 | 4 | 0 | 4 |
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This study was terminated early due to insufficient recruitment. Only four participants in total participated in the study with three completing and one discontinuation.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts,or presentations regarding this study 60 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000608232 | N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide |
| D000068737 | Tolterodine Tartrate |
| D018890 | Chemoprevention |
| D064704 | Levofloxacin |
| D002506 | Cephalexin |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
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| Male |
|
Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg. |
|
| Placebo |
Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg. |
|
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| OG003 |
| Placebo |
Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg. |
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