Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01222650
  4. Details
NCT01222650 Clinical Trial

A Comparative Study of KSO-0400 in BPH Patients With LUTS

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicentre Study of KSO-0400 in BPH Patients With LUTS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01222650
Other study ID # KSO1201
Secondary ID
Status Completed
Phase Phase 2
First received October 15, 2010
Last updated June 30, 2011

Study information
Verified date June 2011
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- BPH patients with LUTS

Exclusion Criteria:

- Patients with a history of prostatectomy, intrapelvic radiation therapy, thermotherapy of prostate or prostatic hyperthermia

- Patients with prostate cancer or suspected prostate cancer

- Patients who have any clinically relevant cardiovascular, hepatic or renal disorder

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• KSO-0400

• KSO-0400

• Silodosin

• Placebo

Locations
Country Name City State
Japan Japan Kanto region

Sponsors (1)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in I-PSS Total Score from baseline Baseline and 12 weeks (LOCF) No
Secondary Change in I-PSS Sub-score from baseline Baseline and 12 weeks (LOCF) No
Secondary Change in QOL Score from baseline Baseline and 12 weeks (LOCF) No
Secondary Change in Qmax (maximum urinary flow rate) from baseline Baseline and 12 weeks (LOCF) No
See also
  Status Clinical Trial Phase
Completed NCT03052049 - Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres N/A
Recruiting NCT04757116 - Post-Market Study to Assess iTind Safety in Comparison to UroLift N/A
Completed NCT03460873 - Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Completed NCT01218243 - An Efficacy Trial of Electroacupuncture at Points of Bilateral BL33 for Mild and Moderate Benign Prostatic Hyperplasia Phase 2
Completed NCT01566292 - Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy Phase 2/Phase 3
Active, not recruiting NCT00407953 - PROLIEVE® Post-Marketing Study TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) Phase 4
Completed NCT03191734 - French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue N/A
Recruiting NCT04838769 - REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men N/A
Completed NCT03856242 - Benign Prostatic Hyperplasia and Ischemic Heart DIsease Phase 4
Completed NCT04032067 - Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT02505919 - Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) N/A
Completed NCT02855892 - A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH Phase 2
Completed NCT02145208 - Study to Assess the Efficacy of Medi-Tate iTind Device N/A
Completed NCT00970632 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Phase 3
Recruiting NCT02592473 - Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia N/A
Completed NCT00945490 - Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018 Phase 3
Completed NCT00759135 - Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate) Phase 2
Completed NCT00224107 - A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo Phase 3
Recruiting NCT04648176 - Application of MOSES Technology in BPH N/A
Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2