Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions

Neurogenic Bladder Disorder Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety and Tolerability of SAF312 in Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions Who Are Inadequately Managed by Antimuscarinic Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01598103
• Other study ID #: CSAF312A2202
• Secondary ID: 2010-021137-32
• Status: Terminated
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with neurogenic detrusor overactivity due to spinal cord lesions

• Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL

Exclusion Criteria:

• Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

• Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function

Related Conditions & MeSH terms

• Neurogenic Bladder Disorder
• Neurogenic Bladder, Spastic
• Neurogenic Bladder, Uninhibited
• Neurogenic Dysfunction of the Urinary Bladder
• Neurogenic Urinary Bladder
• Urinary Bladder Diseases
• Urinary Bladder, Neurogenic
• Urinary Bladder, Overactive

Intervention

Drug:
• SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
• Placebo to SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Murnau
Netherlands	Novartis Investigative Site	Nijmegen
Switzerland	Novartis Investigative Site	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland, 

References & Publications (3)

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. — View Citation

Schäfer W, Abrams P, Liao L, Mattiasson A, Pesce F, Spangberg A, Sterling AM, Zinner NR, van Kerrebroeck P; International Continence Society. Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn. 2002;21(3):261-74. — View Citation

Stöhrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum cystometric capacity (MCC)	Examined during filling cystometry as measured by changes from baseline following treatment for one week.	1 week
Secondary	Number of Participants with Adverse Events as a Measure of Safety	Safety (physical exam, vital signs, haematology, coagulation parameters, clinical chemistry and urinalysis, ECG, pregnancy test, hand immersion test and PK [concentrations of SAF312 in blood]).	1 week
Secondary	Bladder threshold vol, threshold pressure, instilled vol at first leak, detrusor pressure at first leak, vol/detrusor pressure at first sensation and at first desire to void, maximum detrusor pressure during filling/storage, bladder wall compliance	All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week	1 week
Secondary	Micturition or catheterization frequency	Changes from baseline, as measured by daily diaries.	1 week
Secondary	Incontinence episodes	Changes from baseline as measured by daily diaries.	1 week

External Links

•   Results for CSAF312A2202 on the Novartis clinical trials website