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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01598103

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Maximum cystometric capacity (MCC) [1 week]
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 [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
Micturition or catheterization frequency [1 week]
Changes from baseline, as measured by daily diaries.
Incontinence episodes [1 week]
Changes from baseline as measured by daily diaries.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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