We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 )
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Maximum cystometric capacity (MCC) [ Time Frame: 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 [ 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.


Enrollment: 9
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598103


Locations
Germany
Novartis Investigative Site
Murnau, Germany, D-82419
Netherlands
Novartis Investigative Site
Nijmegen, Netherlands
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8008
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01598103     History of Changes
Other Study ID Numbers: CSAF312A2202
2010-021137-32 ( EudraCT Number )
First Submitted: February 17, 2012
First Posted: May 15, 2012
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Neurogenic detrusor overactivity
spinal cord lesions
spinal cord injury

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Bladder Diseases
Neurologic Manifestations
Nervous System Diseases
Urologic Diseases
Signs and Symptoms