Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00969254
Status:
UNKNOWN
Last Update Posted:
2009-09-01
First Post:
2009-08-31
Brief Title:
Study to Assess the Efficacy and Safety of Pílulas de Lussen Compared to the Pyridium in the Symptomatic Control of Dysuria
Sponsor:
Laboratorios Osorio de Moraes Ltda
Organization:
Laboratorios Osorio de Moraes Ltda
Study Overview
Official Title:
Phase III Clinical Study Prospective Multicenter Double-blind Randomized Double-dummy to Assess the Efficacy and Safety of Pílulas de Lussen Compared to the Pyridium in the Symptomatic Control of Dysuria
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
NOT_YET_RECRUITING
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:
E01OSMPLS0108
Brief Summary:
Clinical Study prospective comparative randomized double-dummy entry with random from a total of 80 patients 40 patients will receive the test medication Pílulas de Lussen plus placebo and 40 patients will receive the comparative Pyridium plus placebo
Detailed Description:
Phase III Clinical Study prospective multicenter double-blind randomized double-dummy to assess the efficacy and safety of Pílulas de Lussen compared to the Pyridium in the symptomatic control of dysuria in 80 patients of either sex or race older than 18 years with symptoms of dysuria 40 patients will receive the test medication Pílulas de Lussen plus placebo and 40 patients will receive the comparative Pyridium plus placebo to evaluate the effectiveness and tolerability of Pílulas de Lussen for symptomatic relief of dysuria
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