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

Primary Purpose

Neurogenic Urinary Bladder, Neurogenic Bladder Disorder, Neurogenic Dysfunction of the Urinary Bladder

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

SAF312

Placebo to SAF312

About this trial

This is an interventional treatment trial for Neurogenic Urinary Bladder focused on measuring Neurogenic detrusor overactivity, spinal cord lesions, spinal cord injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo to SAF312

SAF312

Arm Description

Outcomes

Primary Outcome Measures

Maximum cystometric capacity (MCC)

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

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

All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week

Micturition or catheterization frequency

Changes from baseline, as measured by daily diaries.

Incontinence episodes

Changes from baseline as measured by daily diaries.

Full Information

NCT ID

NCT01598103

First Posted

February 17, 2012

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01598103

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurogenic Urinary Bladder, Neurogenic Bladder Disorder, Neurogenic Dysfunction of the Urinary Bladder, Neurogenic Bladder, Uninhibited, Neurogenic Bladder, Spastic

Keywords

Neurogenic detrusor overactivity, spinal cord lesions, spinal cord injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo to SAF312

Arm Type

Placebo Comparator

Arm Title

SAF312

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SAF312

Intervention Description

One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)

Intervention Type

Drug

Intervention Name(s)

Placebo to SAF312

Intervention Description

One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)

Primary Outcome Measure Information:

Title

Maximum cystometric capacity (MCC)

Description

Examined during filling cystometry as measured by changes from baseline following treatment for one week.

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety

Description

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]).

Time Frame

1 week

Title

Description

All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week

Time Frame

1 week

Title

Micturition or catheterization frequency

Description

Changes from baseline, as measured by daily diaries.

Time Frame

1 week

Title

Incontinence episodes

Description

Changes from baseline as measured by daily diaries.

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Murnau

ZIP/Postal Code

D-82419

Country

Germany

Facility Name

Novartis Investigative Site

City

Nijmegen

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zürich

ZIP/Postal Code

8008

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

11857671

Citation

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. doi: 10.1002/nau.10052. No abstract available.

Results Reference

background

PubMed Identifier

11948720

Citation

Schafer 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. doi: 10.1002/nau.10066.

Results Reference

background

PubMed Identifier

19403235

Citation

Stohrer 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.

Results Reference

background

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9783

Description

Results for CSAF312A2202 on the Novartis clinical trials website

Learn more about this trial

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

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