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A Study of the Pharmacokinetics and Pharmacodynamics of MK4618 in Women With Overactive Bladder (MK-4618-004 AM1)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder; Overactive Urinary Bladder

Intervention: MK-4618 (Drug); Tolterodine ER (Drug); MK-1468 and Tolterodine ER (Drug); Placebo (MK-4618) (Other); Placebo (Tolterodine ER) (Other); Prophylactic Antibiotic (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.


The study is designed to investigate the effects of an investigational drug, MK-4618 on maximum urinary bladder capacity 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in maximum cystometric capacity at post-dose on Day 7 in each treatment period

Secondary outcome: Change from baseline of volume of urine at first desire to void

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.


Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Female.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

- Urinary catheter, either permanent or intermittent placement

- Failure to meet medication profile requirements or directives required for study


- 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

Locations and Contacts

Additional Information

Starting date: February 2012
Last updated: January 8, 2015

Page last updated: August 23, 2015

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