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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neurogenic Detrusor Overactivity

Intervention: Solifenacin succinate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Clinical Study Manager, Study Chair, Affiliation: Astellas Pharma Europe B.V.

Summary

The purpose of this study is to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents. NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder. The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies. The efficacy and safety of the solifenacin suspension will be investigated. The take-up and length of time that the solifenacin suspension stays in the body will also be investigated during this study. The study will last for approximately 12 months, where completing patients will receive 52 weeks of continuous treatment. Effectiveness will be measured by urodynamics (the filling and emptying of the bladder) and urine volumes measured during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days. Safety assessments include analysis of the blood and urine, review of the ECG, ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).

Clinical Details

Official title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in maximum cystometric capacity (MCC)

Secondary outcome:

Change in Maximum Cystometric Capacity (MCC)

Change in Urodynamics

Change in Diary Observations

Change in Quality of Life

Eligibility

Minimum age: 5 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Documented diagnosis of NDO, confirmed by urodynamics

- Practicing clean intermittent catheterization (CIC)

- Currently on treatment with an antimuscarinic drug

Exclusion Criteria:

- Known genitourinary condition (other than NDO) that may cause incontinence

- Bladder augmentation surgery

- Current Faecal impaction

- Electro-stimulation therapy within 2 weeks prior to screening and at any time during

the study

- Subjects with the following gastro-intestinal problems: partial or complete

obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention

- Reflux grade 3 or 4

- Current urinary tract infection (UTI)

- Subject has severe renal impairment (glomerular filtration rate < 30 ml/min)

- Subject has severe hepatic impairment (Child-Pugh score > 9).

- Subject has received intra-vesical botulinum toxin within 9 months prior to screening

Locations and Contacts

Site: 3201, Gent 9000, Belgium

Site: 5504, Campinas 13083-887, Brazil

Site: 5506, Campinas, Brazil

Site: 5507, Curitiba, Brazil

Site: 5503, Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Site: 5505, São José do Rio Preto - SP 15090-000, Brazil

Site: 4501, Århus N DK-8200, Denmark

Site: 3602, Miskolc, Hungary

Site: 8201, Seoul 120752, Korea, Republic of

Site: 8207, Seoul 110744, Korea, Republic of

Site: 5203, Leon, GTO 37000, Mexico

Site: 5205, Mexico City, Mexico

Site: 6301, Manila 1015, Philippines

Site: 6302, Quezon City, Philippines

Site: 4803, Gdansk, Poland

Site: 4805, Gdansk, Poland

Site: 4801, Warszawa 04-730, Poland

Site: 9001, Ankara 6100, Turkey

Site: 9003, Ankara 6100, Turkey

Site: 9002, Izmir 35100, Turkey

Site: 1008, Tarrytown, New York 10591, United States

Site: 1010, Cincinnatti, Ohio 45229, United States

Additional Information

Starting date: September 2012
Last updated: July 27, 2015

Page last updated: August 23, 2015

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