Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371033
Status:
UNKNOWN
Last Update Posted:
2011-03-16
First Post:
2006-08-31
Brief Title:
Efficacy Safety Study of Pregabalin to Treat Chronic ProstatitisChronic Pelvic Pain Syndrome CPCPPS
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Randomized Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic ProstatitisChronic Pelvic Pain Syndrome CPCPPS
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
ACTIVE_NOT_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:
CPCRN RCT2
Brief Summary:
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic ProstatitisChronic Pelvic Pain Syndrome
Detailed Description:
Primary Objectives
1 To compare six 6 weeks of treatment with pregabalin versus placebo in CPCPPS participants with respect to the primary endpoint in the NIH-CPSI
2 To evaluate the safety and tolerability of six 6 weeks of pregabalin in CPCPPS participants
Design
Eligible participants will receive either pregabalin or placebo randomly assigned at a ratio of 21 Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily to maximum tolerated dose Participants will be advised to take the study medication 3 times per day There are 3 clinic visits and 2 telephone contacts Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts
1 To compare six 6 weeks of treatment with pregabalin versus placebo in CPCPPS participants with respect to the primary endpoint in the NIH-CPSI
2 To evaluate the safety and tolerability of six 6 weeks of pregabalin in CPCPPS participants
Design
Eligible participants will receive either pregabalin or placebo randomly assigned at a ratio of 21 Study treatment will be for 6 weeks with dose starting at 150mg going up to 300mg and finally to 600mg daily to maximum tolerated dose Participants will be advised to take the study medication 3 times per day There are 3 clinic visits and 2 telephone contacts Participants will be offered optional active treatment for an additional 6 weeks at the end of the first 6 weeks For those participating in both phases there are a total of 4 clinic visits and 5 telephone contacts
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