NCT01565694

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Completed Phase 3 Results posted Last updated 14 November 2024

What this trial tests

Phase 3 trial testing Solifenacin succinate in Neurogenic Detrusor Overactivity in 76 participants. Completed in 28 April 2016.

Timeline

14 August 2012

Primary endpoint
28 April 2016

28 April 2016

Quick facts

Lead sponsor	Astellas Pharma Europe B.V.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	14 August 2012
Primary completion	28 April 2016
Estimated completion	28 April 2016
Sites	21 locations across Denmark, Belgium, Hungary, Mexico, Philippines, Poland, South Korea, United States

Drugs / interventions tested

• Solifenacin succinate — full drug profile →

Conditions studied

• Neurogenic Detrusor Overactivity — all drugs for Neurogenic Detrusor Overactivity →

Sponsor

Astellas Pharma Europe B.V. — full company profile →

Who can join

Adults 5 to 17, any sex, with Neurogenic Detrusor Overactivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) Primary · Baseline and Week 24

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	57.2	± 107.7

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	59.3	± 107.5

Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity Secondary · Baseline, Week 9 or Week 12

During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.

Group	Value	95% CI
Solifenacin Succinate	57.4	± 105.5

Change From Baseline in Bladder Compliance Secondary · Baseline and Week 24

Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	9.1	± 28.6

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	8.8	± 27.8

Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC) Secondary · Baseline and Week 24

Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.

Group	Value	95% CI
Solifenacin Succinate	23.10	-117.2 – 114.7

Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure Secondary · Baseline and Week 24

Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	61.8	± 80.6

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	71.9	± 88.3

Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure Secondary · Baseline and Week 24

Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	67.0	± 44.3

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	54.4	± 52.9

Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling Secondary · Baseline to Week 24

Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	-2.3	± 5.1

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	-1.8	± 6.0

Change From Baseline in Detrusor Pressure at the End of Bladder Filling Secondary · Baseline to Week 24

The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	-9.2	± 33.6

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	-8.2	± 32.2

Change From Baseline in Average Catheterized Volume Per Catheterization Secondary · Baseline to Week 24

The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	46.23	± 48.32

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	48.86	± 50.98

Change From Baseline in Maximum Catheterized Volume Secondary · Baseline to Week 24

The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	67.45	± 88.07

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	69.63	± 88.84

Change From Baseline in Average First Morning Catheterized Volume Secondary · Baseline to Week 24

The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	43.24	± 72.78

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	44.21	± 73.40

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Secondary · Baseline to Week 24

The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.

Change from Baseline Week 24

Group	Value	95% CI
Solifenacin Succinate	-1.60	± 2.04

Change from Baseline Week 24 (LOCF)

Group	Value	95% CI
Solifenacin Succinate	-1.62	± 2.04

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug to the last dose of study drug (up to week 52).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Solifenacin Succinate

Serious: 7/76 (9%)

Deaths: 0/76

Serious adverse events (8 terms)

Reaction	System	Solifenacin Succinate
Tachycardia	Cardiac disorders	—
Megacolon	Gastrointestinal disorders	—
Dengue fever	Infections and infestations	—
Orchitis	Infections and infestations	—
Urinary tract infection bacterial	Infections and infestations	—
Tethered cord syndrome	Nervous system disorders	—
Spinal cord operation	Surgical and medical procedures	—
Hypertension	Vascular disorders	—

Other adverse events (11 terms — click to expand)

Reaction	System	Solifenacin Succinate
Urinary tract infection bacterial	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Constipation	Gastrointestinal disorders	—
Escherichia urinary tract infection	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Electrocardiogram QT prolonged	Investigations	—
Headache	Nervous system disorders	—
Bladder pain	Renal and urinary disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Decubitus ulcer	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Tachycardia, Megacolon, Dengue fever, Orchitis, Urinary tract infection bacterial, Tethered cord syndrome, Spinal cord operation, Hypertension.

Data from ClinicalTrials.gov NCT01565694 adverse events section.

Sponsor's own description

The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies.
   Franco I, Hoebeke P, Baka-Ostrowska M, Bolong D, et al · · 2020 · cited 12× · PMID 32007426 · DOI 10.1016/j.jpurol.2019.12.012
2. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity.
   Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, et al · · 2020 · cited 4× · PMID 33231929 · DOI 10.1002/prp2.684