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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00174798

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: SSR240600C	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo and Active-Controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI)

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: SSR240600

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	81
Study Start Date:	May 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174798

Show 22 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ACT5190, SSR240600C
Study First Received:	September 13, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00174798 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Cystometry NK1 Antagonist SSR240600C

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence
Urinary Incontinence, Urge

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence
Urinary Incontinence, Urge

ClinicalTrials.gov processed this record on September 02, 2009