CLINICAL TRIALS PROFILE FOR RAPAFLO

All Clinical Trials for RAPAFLO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00224107 ↗	A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo	Completed	Watson Pharmaceuticals	Phase 3	2005-05-01	A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
NCT00224120 ↗	A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo	Completed	Watson Pharmaceuticals	Phase 3	2005-05-01	A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
NCT00224133 ↗	The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months	Completed	Watson Pharmaceuticals	Phase 3	2005-09-01	A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
NCT00740779 ↗	Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.	Completed	Watson Pharmaceuticals	Phase 2	2008-09-01	The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.
NCT00793819 ↗	A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia	Completed	Watson Pharmaceuticals	Phase 2	2009-01-01	Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH
NCT02220829 ↗	Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy	Recruiting	Sir Mortimer B. Davis - Jewish General Hospital	Phase 3	2016-06-01	Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop symptomatic urinary problems .These symptoms can significantly diminish a patient's quality of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease resistance to urinary flow. This multi-institutional phase III trial is designed to compare standard of care versus preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group, whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy or if/when symptoms appear.
NCT02369744 ↗	Silodosin Versus Tamsulosin for Treatment of Ureteral Stones	Terminated	Albert Einstein Healthcare Network	Phase 4	2013-03-01	Ureteral calculi, commonly known as kidney stones, are a frequent cause of Emergency Department (ED) visits. These stones can get caught in the ureter (the tube connecting the kidney to the bladder) and cause symptoms including pain, nausea, and vomiting. As long as the obstructing stone meets certain conditions and the patient isn't too sick, the patient is usually sent home to try and pass the stone without surgery. This treatment is known as medical expulsive therapy (MET), and routinely involves the use of a drug called tamsulosin, which relaxes the smooth muscle of the urinary system to help the stone pass. Silodosin is a drug in the same class of tamsulosin, but which is thought to have a more selective action and a quicker onset, which would theoretically make it better for aiding in kidney stone passage. The purpose of this study is a head-to-head, blinded comparison of these two drugs to see how quickly they result in stone passage. Subjects are patients presenting to the ED with acute kidney stone shown by CT scan, and who are appropriate for MET. The main study intervention is randomization to receiving either tamsulosin or silodosin. The hypothesis is that silodosin will have decreased time to stone passage compared to tamsulosin. Subjects who qualify and consent are randomized to a two-week course of either silodosin or tamsulosin. They are also given prescriptions for standard of care medications for pain and nausea, as well as a pain diary. They receive a follow-up phone call after one week to remind them of their follow-up appointment, ask about adverse events, and determine if their stone has passed. They have a follow-up visit with study staff at the end of their two week treatment to collect their pain diary, pill count, adverse events, and to determine if their stone has passed. Study participation ends after this follow-up visit.

Clinical Trial Conditions for RAPAFLO

Condition Name

Condition Name for RAPAFLO
Intervention	Trials
Benign Prostatic Hyperplasia	2
Ureterolithiasis	1
Urinary Problems	1
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome	1

Condition MeSH

Condition MeSH for RAPAFLO
Intervention	Trials
Prostatic Hyperplasia	4
Hyperplasia	4
Pelvic Pain	1
Calculi	1

Clinical Trial Locations for RAPAFLO

Trials by Country

Trials by Country for RAPAFLO
Location	Trials
United States	116
Canada	1

Trials by US State

Trials by US State for RAPAFLO
Location	Trials
New York	5
Pennsylvania	5
California	5
Washington	5
Oklahoma	4

Clinical Trial Progress for RAPAFLO

Clinical Trial Phase

Clinical Trial Phase for RAPAFLO
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for RAPAFLO
Clinical Trial Phase	Trials
Completed	5
Terminated	1
Recruiting	1

Clinical Trial Sponsors for RAPAFLO

Sponsor Name

Sponsor Name for RAPAFLO
Sponsor	Trials
Watson Pharmaceuticals	5
Sir Mortimer B. Davis - Jewish General Hospital	1
Albert Einstein Healthcare Network	1

Sponsor Type

Sponsor Type for RAPAFLO
Sponsor	Trials
Industry	5
Other	2