Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103402
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2005-02-07
Brief Title:
Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic ProstatitisChronic Pelvic Pain Syndrome
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 Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis Chronic Pelvic Pain Syndrome CPCPPS in Recently-Diagnosed andor Newly-Symptomatic Alpha-blocker Naïve Patients
Status:
COMPLETED
Status Verified Date:
2020-05
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:
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin Uroxatral in men with relatively new onset of chronic prostatitischronic pelvic pain syndrome CPCPPS Alfuzosin is a once daily 10 mg capsule FDA approved medication for an indication in benign prostatic hyperplasia BPH The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies A number of small studies have also suggested that alfuzosin ameliorates CPCPPS symptoms through a similar alpha-blockade mechanism This study will enable further testing of this hypothesis
Detailed Description:
The two primary objectives of this study are
To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed alpha-blocker naive CPCPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index NIH-CPSI
To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed alpha-blocker naïve CPCPPS participants
The proportion of responders in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo Approximately 270 eligible patients 135 per treatment arm will be randomized and followed for a period of twelve 12 weeks after randomization
There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected visit 1 involves screening visit 2 involves collection of baseline data and randomization visit 3 is the 6-week evaluation and visit 4 is the 12-week evaluation of the primary end point
To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed alpha-blocker naive CPCPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index NIH-CPSI
To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed alpha-blocker naïve CPCPPS participants
The proportion of responders in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo Approximately 270 eligible patients 135 per treatment arm will be randomized and followed for a period of twelve 12 weeks after randomization
There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected visit 1 involves screening visit 2 involves collection of baseline data and randomization visit 3 is the 6-week evaluation and visit 4 is the 12-week evaluation of the primary end point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U01DK065209 | NIH | NIDDK | httpsreporternihgovquickSearchU01DK065209 |
| RFA-DK-03-004 | OTHER_GRANT | None | None |