Clinical Trials Logo
  1. Home
  2. Prostatic Hyperplasia
  3. NCT00290030
  4. Details
NCT00290030 Clinical Trial

ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

Prostatic Hyperplasia Clinical Trial

Official title:
A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00290030
Other study ID # EFC4428
Secondary ID SL 770499-10
Status Completed
Phase Phase 3
First received February 9, 2006
Last updated March 10, 2009
Start date May 2001
Est. completion date October 2004

Study information
Verified date March 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH.

To assess the safety of alfuzosin in this population and health care consumption.

Description:

Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal.

Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Male aged over 50 years

- Having given his written consent

- Presenting with a first episode of painful acute urinary retention related to BPH

- With a catheterized urine volume between mL and mL at the time of retention

Exclusion Criteria:

- Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin

- Iatrogenic causes of urinary retention

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Alfuzosin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Outcome
Type Measure Description Time frame Safety issue
Primary Successful voiding in initial period (using an active voiding trial)
Primary No relapse during the 6 month treatment period
Primary No need / indication for surgery during the initial or 6 month treatment periods
Secondary To assess the safety of alfuzosin in this population, and health care consumption
See also
  Status Clinical Trial Phase
Completed NCT02578953 - Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects Phase 1
Terminated NCT02396420 - Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams Phase 2
Terminated NCT04398966 - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT02947958 - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia N/A
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT00427882 - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study Phase 4
Completed NCT02244320 - Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin) N/A
Completed NCT01254071 - A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. Phase 1
Recruiting NCT04108871 - Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men N/A
Recruiting NCT05686525 - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH N/A
Completed NCT01957189 - This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples Phase 1
Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
Completed NCT02715401 - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers Phase 1
Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
Completed NCT01482676 - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction N/A
Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
Completed NCT00822952 - Prostate Mechanical Imager (PMI) Clinical Bridging Study N/A
Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00563654 - Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A

External Links