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

Phase 2

Terminated

• Conditions: Neurogenic Urinary Bladder; Neurogenic Dysfunction of the Urinary Bladder; Neurogenic Bladder Disorder; Neurogenic Bladder, Spastic; Neurogenic Bladder, Uninhibited
• Interventions: Drug: Placebo to SAF312; Drug: SAF312

• Registration Number: NCT01598103
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-04
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-28
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo to SAF312	Placebo to SAF312	-
SAF312	SAF312	-

Primary Outcome Measures

Name	Time	Method
Maximum cystometric capacity (MCC)	1 week	Examined during filling cystometry as measured by changes from baseline following treatment for one week.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety	1 week	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	1 week	All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week
Incontinence episodes	1 week	Changes from baseline as measured by daily diaries.
Micturition or catheterization frequency	1 week	Changes from baseline, as measured by daily diaries.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zürich, Switzerland