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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598103
First Posted: May 15, 2012
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
February 17, 2012
May 15, 2012
April 27, 2016
January 2012
September 2012   (Final data collection date for primary outcome measure)
Maximum cystometric capacity (MCC) [ Time Frame: 1 week ]
Examined during filling cystometry as measured by changes from baseline following treatment for one week.
Change in maximum cystometric capacity (MCC) following one week of treatment versus baseline. [ Time Frame: 1 week ]
Complete list of historical versions of study NCT01598103 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 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 [ Time Frame: 1 week ]
    All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week
  • Micturition or catheterization frequency [ Time Frame: 1 week ]
    Changes from baseline, as measured by daily diaries.
  • Incontinence episodes [ Time Frame: 1 week ]
    Changes from baseline as measured by daily diaries.
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 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 volume [ Time Frame: 1 week ]
    Bladder threshold volume, threshold pressure, instilled volume at first leak, detrusor pressure at first leak, volume/detrusor pressure at first sensation, volume/detrusor pressure at first desire to void, maximum detrusor pressure during filling/storage phase, bladder wall compliance
  • Changes from baseline with respect to micturition or catheterization frequency as measured by daily diaries. [ Time Frame: 1 week ]
  • Changes from baseline with respect to incontinence episodes as measured by daily diaries. [ Time Frame: 1 week ]
Not Provided
Not Provided
 
Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Neurogenic Urinary Bladder
  • Neurogenic Bladder Disorder
  • Neurogenic Dysfunction of the Urinary Bladder
  • Neurogenic Bladder, Uninhibited
  • Neurogenic Bladder, Spastic
  • Drug: SAF312
    One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
  • Drug: Placebo to SAF312
    One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
  • Placebo Comparator: Placebo to SAF312
    Intervention: Drug: Placebo to SAF312
  • Experimental: SAF312
    Intervention: Drug: SAF312

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands,   Switzerland
Belgium,   United States
 
NCT01598103
CSAF312A2202
2010-021137-32 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP