Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409539
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2006-12-08
Brief Title:
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome OABS
Sponsor:
Sumitomo Pharma America Inc
Organization:
Sumitomo Pharma America Inc
Study Overview
Official Title:
A 10-week Randomised DB PG PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 20 40 80 and 120 mg Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome
Status:
COMPLETED
Status Verified Date:
2014-12
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:
SMP-986 is a compound being developed for the treatment of overactive bladder syndrome OABS This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg 40mg 80mg or 120mg provides greater symptom relief in OABS compared to placebo The hypothesis will be tested by measuring the change in mean voids24 hrs after treatment with SMP-986 compared to placebo as well comparing the change in the severity of urgency episodes mean number of urgency episodes24 hr mean number of incontinence episodes24 hr and the mean void volumevoid between SMP-986 and placebo
Detailed Description:
A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized double-blind placebo controlled treatment period with patients randomized to receive 20 mg 40 mg 80 mg or 120 mg SMP 986 or placebo in a 11111 ratio in parallel groups on an outpatient basis with study center visits
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