Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338624
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2006-06-16
Brief Title:
An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX Tamsulosin HCl and Placebo Plus FLOMAX Tamsulosin HCl for the Treatment of Lower Urinary Tract Symptoms
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
A Double-Blind Randomized Parallel Group Trial of Ditropan XL Oxybutynin Chloride Extended Release Tablets or Placebo in Combination With FLOMAX Tamsulosin Hydrochloride for the Treatment of Lower Urinary Tract Symptoms
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 04 mg in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score I-PSS from baseline to Week 12 or the Final Visit
Detailed Description:
The objective of this double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage randomized patients are assigned different treatments based on chance parallel group trial is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg per day for 12 weeks in conjunction with an alpha-blocker for the treatment of lower urinary tract symptoms LUTS The hypothesis of the study is that oxybutynin extended release tablets 10 mg plus tamsulosin 04 mg will be more effective than tamsulosin 04 mg plus placebo in the treatment of lower urinary tract symptoms as measured by change of the total International Prostate Symptom Score I-PSS from baseline to Week 12 or the Final Visit Safety assessments include Peak Flow Rate PFR and Post-Void Residual PVR volume adverse events vital signs and physical exams Patients will receive oxybutynin extended release 10 mg plus tamsulosin 04 mg or placebo plus tamsulosin 04 mg every day for 12 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