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

NCT01598103 | Terminated Phase 2

• 2 other identifiers: CSAF312A22022010-021137-32
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Maximum cystometric capacity (MCC)

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

  1 week

Secondary Outcomes (4)

• Number of Participants with Adverse Events as a Measure of Safety

  1 week

• 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

• Micturition or catheterization frequency

  1 week

• Incontinence episodes

  1 week

Study Arms (2)

Placebo to SAF312

PLACEBO COMPARATOR

Drug: Placebo to SAF312

SAF312

EXPERIMENTAL

Drug: SAF312

Interventions

SAF312 DRUG

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

SAF312

Placebo to SAF312 DRUG

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

Placebo to SAF312

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Murnau am Staffelsee, D-82419, Germany

Location

Novartis Investigative Site

Nijmegen, Netherlands

Location

Novartis Investigative Site

Zurich, 8008, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 11857671 BACKGROUND

• 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.

  PMID: 11948720 BACKGROUND

• 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.

  PMID: 19403235 BACKGROUND

Related Links

• Results for CSAF312A2202 on the Novartis clinical trials website

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: May 15, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 19, 2020

Record last verified: 2016-04

Locations

DE (1); CH (1); NL (1)