A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity

NCT ID: NCT00712322

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-07
• Study Completion Date: 2013-05-23

Brief Summary

This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

Conditions

Neurogenic Detrusor Overactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (Darifenacin 0.030 mg/kg/day)

Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.030 milligrams/kilogram/day (mg/kg/day) dispensed per twice a day (BID) dosing, for 14 days.

Group Type: EXPERIMENTAL

Darifenacin

Intervention Type: DRUG

Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.

Cohort 2 (Darifenacin 0.0625 mg/kg/day)

Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days.

Group Type: EXPERIMENTAL

Darifenacin

Intervention Type: DRUG

Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.

Cohort 3 (Darifenacin 0.125 mg/kg/day)

Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days.

Group Type: EXPERIMENTAL

Darifenacin

Intervention Type: DRUG

Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.

Interventions

Darifenacin

Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.

Intervention Type: DRUG

Other Intervention Names

Enablex®, Emselex®, DAR328

Eligibility Criteria

Inclusion Criteria

• Male and female participants ages 2-15 years
• Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline
• Using clean intermittent catheterization (CIC) on a regular basis
• Participating in a bowel program on a regular basis
• Able to swallow the study medication in accordance to the protocol
• Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures

Exclusion Criteria

• Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function
• Fecal impaction. Participants may be included, once this condition has resolved
• Clinically significant anatomical abnormalities or acquired disorders of the urinary tract
• Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet
• Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
• Diabetes insipidus
• Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study
• Concomitant diseases, in which the use of darifenacin is contraindicated
• History of hypersensitivity to darifenacin or to drugs with similar chemical structures
• Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion
• Female adolescent of child-bearing potential, unless using an acceptable method of contraception

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Warner Chilcott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herman Ellman, MD

Role: STUDY_DIRECTOR

Warner Chilcott (US) LLC

Locations

University of California at San Diego

San Diego, California, United States

Children's Hospital, Karp 8210

Boston, Massachusetts, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Washington University Pediatric Urology

St Louis, Missouri, United States

Pediatric Urology Associates, PC

Lake Success, New York, United States

Pediatric Urology Associates PC

Tarrytown, New York, United States

Pediatric & Adolescent Urology, Inc Akron Children's Hospital

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Fundacion Hospital Infantil, Universitario De San Jose

Bogotá, , Colombia

Fundación Valle de Lili

Cali, , Colombia

Hospital Pablo Tobon Uribe

Medellín, , Colombia

Countries

United States; Colombia

Other Identifiers

CDAR328B2201

Identifier Type: -

Identifier Source: org_study_id