Neurogenic Detrusor OveractivityPhase 2NCT00712322
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
A Phase 2 study testing Darifenacin in people with Neurogenic Detrusor Overactivity, run by Warner Chilcott at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Neurogenic Detrusor Overactivity
- What is being tested?
- Darifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 7 Oct 2008to 23 May 2013
- Phase
- Phase 2
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
- Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Pediatric & Adolescent Urology, Inc Akron Children's Hospital
Akron, Ohio, 44302
Children's Hospital, Karp 8210
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Michigan
Detroit, Michigan, 48201-2119
Pediatric Urology Associates, PC
Lake Success, New York, 11042
Oregon Health & Science University
Portland, Oregon, 97239
University of California at San Diego
San Diego, California, 92123
Washington University Pediatric Urology
St Louis, Missouri, 63110
Pediatric Urology Associates PC
Tarrytown, New York, 10591
Colombia3 sites
Fundacion Hospital Infantil, Universitario De San Jose
Bogotá
Fundación Valle de Lili
Cali
Hospital Pablo Tobon Uribe
Medellín
About this study
Official title: A 14-day, Open-label, Multicenter, Dose-escalating, Sequential Cohort Study to Evaluate Pharmacodynamics (Urodynamics) and Pharmacokinetics, Clinical Efficacy, Tolerability and Safety Following Multiple Doses (mg/kg/Day) of a Darifenacin Liquid Oral Suspension Given BID in Children, Ages 2 - 15 Years, With Neurogenic Detrusor Overactivity
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
- Being tested
- Darifenacin
- Keywords
- Pediatric, Children, Urodynamics, Oral Suspension, Overactive bladder, Dose-finding, Neurogenic Detrusor Overactivity, Meningomyelocele, Spinal cord injury
- Medical subject headings
- Urinary Bladder, Overactive, Meningomyelocele, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarifenacinDrug
Also called Enablex®, Emselex®, DAR328
Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Darifenacin 0.030 mg/kg/day) | Experimental | 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. Receives: Drug: Darifenacin |
| Cohort 2 (Darifenacin 0.0625 mg/kg/day) | Experimental | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. Receives: Drug: Darifenacin |
| Cohort 3 (Darifenacin 0.125 mg/kg/day) | Experimental | Following a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. Receives: Drug: Darifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Maximum Bladder Capacity (MBC)
MBC was defined as the volume of urine at which significant urinary leakage (i.e. leakage that prevents further volume increase) or significant discomfort/pain occurs, or a detrusor pressure at 40 centimeter (cm) H2O was reached.
Measured: Baseline (Day 0) to Day 14
Secondary outcomes (7)
Change From Baseline in Mean Volume at First Contraction
Average volume of urine collected by catheterization at first contraction.
Measured: Baseline (Day 0) to Day 14
Change From Baseline in Detrusor Pressure at First Contraction
Measured: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at First Detectable Leakage
Average volume of urine collected by catheterization at first detectable leakage.
Measured: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Measured: Baseline (Day 0) to Day 14
Change From Baseline in Mean Catheterization Volume
Average volume of urine was collected by catheterization and was recorded in a bladder diary. Bladder volume was assessed by urodynamics. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement.
Measured: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Change From Baseline in Total Pad Weight In-between Catheterizations
Urodynamic test was used to assess the total pad weight in-between catheterizations. The change in total pad weight in-between catheterizations was recorded in the bladder diary. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement.
Measured: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Change From Baseline in Mean Catheterization Volume at First Awakening
The change in urine volume at first awakening catherization was recorded by the participant in a bladder diary. Bladder volume was assessed by urodynamics. The bladder diary entries completed on any 2 consecutive days after completing wash-out and prior to the baseline urodynamic examination on Visit 2 was used to calculate the baseline (Day-1) i.e. Visit 2 values. Similarly, the bladder diary entries completed on any 2 consecutive days during the week prior to the final study visit on Day 14 i.e. Visit 4 was used to calculate the Visit 4 values. The positive change from baseline indicates improvement.
Measured: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study start7 Oct 2008
- Primary completion23 May 2013
- Study completion23 May 2013
Why it stopped: Due to extremely difficult enrollment.
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 Neurogenic Detrusor OveractivityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herman Ellman, MD, Study director, Warner Chilcott (US) LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712322
- Sponsor's protocol ID
- CDAR328B2201
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2008
- Last updated
- 9 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-day, Open-label, Multicenter, Dose-escalating, Sequential Cohort Study to Evaluate Pharmacodynamics (Urodynamics) and Pharmacokinetics, Clinical Efficacy, Tolerability and Safety Following Multiple Doses (mg/kg/Day) of a Darifenacin Liquid Oral Suspension Given BID in Children, Ages 2 - 15 Years, With Neurogenic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT00712322
- Acronym / sponsor ID
- CDAR328B2201
- Conditions
- Neurogenic Detrusor Overactivity
- Keywords
- Pediatric, Children, Urodynamics, Oral Suspension, Overactive bladder, Dose-finding, Neurogenic Detrusor Overactivity, Meningomyelocele, Spinal cord injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to extremely difficult enrollment.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2008 (actual)
- Primary completion
- 23 May 2013 (actual)
- Study completion
- 23 May 2013 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Darifenacin 0.030 mg/kg/day) | Experimental | Drug: DarifenacinFollowing 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. |
| Cohort 2 (Darifenacin 0.0625 mg/kg/day) | Experimental | Drug: DarifenacinFollowing a 7-day washout period, participants received darifenacin liquid oral suspension, 0.0625 mg/kg/day dispensed per BID dosing, for 14 days. |
| Cohort 3 (Darifenacin 0.125 mg/kg/day) | Experimental | Drug: DarifenacinFollowing a 7-day washout period, participants received darifenacin liquid oral suspension, 0.125 mg/kg/day dispensed per BID dosing, for 14 days. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| DarifenacinAlso: Enablex®, Emselex®, DAR328Following a 7-day washout period, participants received darifenacin liquid oral suspension up to 14 days. | Drug | Cohort 1 (Darifenacin 0.030 mg/kg/day), Cohort 2 (Darifenacin 0.0625 mg/kg/day), Cohort 3 (Darifenacin 0.125 mg/kg/day) |
Primary outcome
Change From Baseline in Mean Maximum Bladder Capacity (MBC)
Time frame: Baseline (Day 0) to Day 14
MBC was defined as the volume of urine at which significant urinary leakage (i.e. leakage that prevents further volume increase) or significant discomfort/pain occurs, or a detrusor pressure at 40 centimeter (cm) H2O was reached.
7 secondary outcomes
Change From Baseline in Mean Volume at First Contraction
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Detrusor Pressure at First Contraction
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at First Detectable Leakage
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Volume at 10, 20, 30, and 40 cm H2O Detrusor Pressure
Time frame: Baseline (Day 0) to Day 14
Change From Baseline in Mean Catheterization Volume
Time frame: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Change From Baseline in Total Pad Weight In-between Catheterizations
Time frame: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Change From Baseline in Mean Catheterization Volume at First Awakening
Time frame: Baseline (Day -1) to 2 consecutive days during the week prior to final study Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herman Ellman, MD study director
Warner Chilcott (US) LLC
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darifenacin in people with Neurogenic Detrusor Overactivity, run by Warner Chilcott at 12 sites in 2 countries.
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 6 inclusion and 12 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Jun 2022). 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?
Change From Baseline in Mean Maximum Bladder Capacity (MBC) (time frame: Baseline (Day 0) to Day 14). 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 9 Jun 2022.