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

Phase 1

Conditions: eurogenic detrusor overactivity due to spinal cord injury
MedDRA version: 14.1Level: PTClassification code 10020853Term: Hypertonic bladderSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-021137-32-BE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 72

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- Assessment of the relationship between pharmacokinetics and pharmaco-dynamics of SAF312<br>- Evaluation of the effects of SAF312 on additional parameters examined during filling cystometry following one week of treatment versus baseline measurements<br>- Changes from baseline with respect to micturition or catheterization frequency as measured by daily diaries<br>- Changes from baseline with respect to incontinence episodes as measured by daily diaries<br>;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

Secondary Outcome Measures