MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.

Sanofi118 enrolled

Overview

To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.

Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

118

Conditions

Overactive Bladder

Interventions

SSR240600CDRUG

once daily

PlaceboDRUG

oral

TolterodineDRUG

once daily

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency) * Bladder capacity \</= 300 mL by cystometry Exclusion Criteria: * History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder * Current urinary tract infection * Neurological bladder dysfunction * Treatment with drugs that may interfere with CYP3A4 metabolic function * History of stress urinary incontinence

Locations (22)

Hope Research LLC

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.

Secondary Outcomes

Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement

Data from ClinicalTrials.gov

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