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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Neurogenic Bladder, Uninhibited; Neurogenic Bladder, Spastic; Neurogenic Dysfunction of the Urinary Bladder; Neurogenic Bladder Disorder; Neurogenic Urinary Bladder

Treatments: Drug: SAF312; Drug: Placebo to SAF312

Study type: Interventional

Funder types: Industry

Identifiers

NCT01598103

CSAF312A2202

2010-021137-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups, including a placebo group

Placebo to SAF312

Placebo Comparator group

Treatment:

Drug: Placebo to SAF312

SAF312

Experimental group

Treatment:

Drug: SAF312