Efficacy and safety of SAF312 in patients with urinary incontinence (malfunctioning bladder) due to spinal cord injury.

A multi-center, double-blind, randomized, placebocontrolled, 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 - Not applicable

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021137-32-BE

Enrollment

Registered

2010-10-19

Start date

2011-03-14

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurogenic detrusor overactivity due to spinal cord injury MedDRA version: 14.1 Level: PT Classification code 10020853 Term: Hypertonic bladder System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: SAF312 Product Code: SAF312 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not known yet CAS Number: 871814-52-7 Current Sponsor code: SAF312 Other descriptive name: 4-(7-Hydrox

Eligibility

Sex/Gender

All

Inclusion 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. 300 mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of the change in maximum cystometric capacity (MCC) following one week of treatment versus baseline ;Secondary Objective: - Evaluation of the safety, tolerability and pharmacokinetics of oral SAF312 administered with a b.i.d. regimen for 1 week - Assessment of the relationship between pharmacokinetics and pharmaco-dynamics of SAF312 - Evaluation of the effects of SAF312 on additional parameters examined during filling cystometry following one week of treatment versus baseline measurements - Changes from baseline with respect to micturition or catheterization frequency as measured by daily diaries - Changes from baseline with respect to incontinence episodes as measured by daily diaries ;Primary end point(s): Change in maximum cystometric capacity (MCC) following one week of treatment versus baseline;Timepoint(s) of evaluation of this end point: After 1 week of treatment	—

Measure

Time frame

Main Objective: Assessment of the change in maximum cystometric capacity (MCC) following one week of treatment versus baseline ;Secondary Objective: - Evaluation of the safety, tolerability and pharmacokinetics of oral SAF312 administered with a b.i.d. regimen for 1 week - Assessment of the relationship between pharmacokinetics and pharmaco-dynamics of SAF312 - Evaluation of the effects of SAF312 on additional parameters examined during filling cystometry following one week of treatment versus baseline measurements - Changes from baseline with respect to micturition or catheterization frequency as measured by daily diaries - Changes from baseline with respect to incontinence episodes as measured by daily diaries ;Primary end point(s): Change in maximum cystometric capacity (MCC) following one week of treatment versus baseline;Timepoint(s) of evaluation of this end point: After 1 week of treatment

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Secondary

Measure	Time frame
Secondary end point(s): - Safety, tolerability and pharmacokinetics of SAF312 - Relationship between pharmacokinetics and pharmacodynamics of SAF312 - Additional parameters examined during filling cystometry following one week of treatment versus baseline measurements - Changes from baseline with respect to micturition or catheterization frequency as measured by daily diaries - Changes from baseline with respect to incontinence episodes as measured by daily diaries ;Timepoint(s) of evaluation of this end point: - Safety, tolerability and pharmacokinetics of SAF312: over the entire study duration - Relationship between pharmacokinetics and pharmacodynamics of SAF312: for a week after treatment administration - Additional parameters examined during filling cystometry following one week of treatment versus baseline measurements: after 1 week of treatment - Changes from baseline with respect to micturition or catheterization frequency and changes from baseline with respect to incontinence episodes: daily for a week	—

Measure

Time frame

Secondary end point(s): - Safety, tolerability and pharmacokinetics of SAF312 - Relationship between pharmacokinetics and pharmacodynamics of SAF312 - Additional parameters examined during filling cystometry following one week of treatment versus baseline measurements - Changes from baseline with respect to micturition or catheterization frequency as measured by daily diaries - Changes from baseline with respect to incontinence episodes as measured by daily diaries ;Timepoint(s) of evaluation of this end point: - Safety, tolerability and pharmacokinetics of SAF312: over the entire study duration - Relationship between pharmacokinetics and pharmacodynamics of SAF312: for a week after treatment administration - Additional parameters examined during filling cystometry following one week of treatment versus baseline measurements: after 1 week of treatment - Changes from baseline with respect to micturition or catheterization frequency and changes from baseline with respect to incontinence episodes: daily for a week

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Countries

Belgium, Germany, Switzerland, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026