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

Purpose

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.

Condition	Intervention	Phase
Neurogenic Urinary Bladder Neurogenic Bladder Disorder Neurogenic Dysfunction of the Urinary Bladder Neurogenic Bladder, Uninhibited Neurogenic Bladder, Spastic	Drug: SAF312 Drug: Placebo to SAF312	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bladder Diseases

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Maximum cystometric capacity (MCC) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Examined during filling cystometry as measured by changes from baseline following treatment for one week.

Secondary Outcome Measures:

Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
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]).
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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week
Micturition or catheterization frequency [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Changes from baseline, as measured by daily diaries.
Incontinence episodes [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Changes from baseline as measured by daily diaries.

Enrollment:	9
Study Start Date:	January 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598103

Locations

Germany
Novartis Investigative Site
Murnau, Germany, D-82419
Netherlands
Novartis Investigative Site
Nijmegen, Netherlands
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8008

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Publications:

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.

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.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01598103 History of Changes
Other Study ID Numbers:	CSAF312A2202, 2010-021137-32
Study First Received:	February 17, 2012
Last Updated:	March 18, 2013
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Novartis:

Neurogenic detrusor overactivity
spinal cord lesions
spinal cord injury

Additional relevant MeSH terms:

Urinary Bladder Diseases
Urinary Bladder, Neurogenic
Urologic Diseases

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013