DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study of the Efficacy and Safety of MK-4618 in Patients With Overactive Bladder (OAB) (MK-4618-008 AM3 EXT1[AM2])

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: Urinary Bladder, Overactive

Intervention: MK-4618 low-dose (Drug); MK-4618 mid-low dose (Drug); MK-4618 mid-high dose (Drug); tolterodine ER (Drug); Placebo for MK-4618 (Drug); Placebo for tolterodine ER (Drug); MK-4618 high dose (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This is a 2-part study to assess if MK-4618 reduces the number of daily urinations more effectively than placebo in participants with overactive bladder (OAB).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change from Baseline in Average Daily Micturitions

Base Study: Number of Participants Who Experienced an Adverse Event (AE) and/ or Serious Adverse Event (SAE)

Extension: Number of Participants Who Discontinued the Study Due to an AE and/or SAE

Extension: Number of Participants Who Experienced an Adverse Event (AE) and/ or Serious Adverse Event (SAE)

Base Study: Number of Participants Who Discontinued the Study Due to an AE and/or SAE

Secondary outcome:

Change from Baseline in Number of Urge Incontinence Episodes

Change from Baseline in Total Incontinence Episodes

Change from Baseline in Number of Strong Urge Episodes

Extension: Change From Extension Baseline in Average Daily Micturitions

Extension: Change from Extension Baseline in Average Daily Urge Incontinence Episodes

Extension: Change from Extension Baseline in Average Daily Total Incontinence Episodes

Extension: Change from Extension Baseline in Average Daily Strong Urge Episodes

Detailed description: Participants who complete the base study may be screened for a year-long, multicenter extension for assessment of long-term safety and efficacy

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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 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

Locations and Contacts

Additional Information

Starting date: March 2011
Last updated: August 4, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017