Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174798
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2005-09-13
Brief Title:
MILADY A Randomized Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SSR240600C | None | None | None |