Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Clinical Effect and Safety of Tamsulosin 0.4mg in Patients With LUTS/BPH Refractory to Tamsulosin 0.2mg

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00954889
• Other study ID #: 2009-05-004
• Status: Active, not recruiting
• Phase: N/A
• First received: August 5, 2009
• Last updated: October 31, 2011
• Start date: August 2009

Study information

• Verified date: October 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).

Description:

Alpha-adrenoreceptor antagonists have become the primary medical treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). The next treatment method is trans-urethral resection of prostate (TURP). TURP is the most efficient BPH treatment for relieving symptoms and improving uroflow, but it is also the invasive and morbid.

Tamsulosin has higher selectivity for the pharmacological a1-adrenoceptor subtype and the cloned a1a subtype than for the a1b subtype. Tamsulosin 0.4 mg improved Qmax to a slightly greater extent than alfuzosin 10 mg.(26% and 16% versus baseline, respectively)(http://www. fda.gov/cder/approval/ index.htm;accessed October 27, 2003.) and Tamsulosin 0.4 mg o.d. has been reported to be well tolerated irrespective of age and/or cardiovascular comorbidity/co-medication (Michel et al 1998) and no interaction with several antihypertensive agents has been reported. (Lowe et al. 1997) Our study is to explore the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® D 0.2mg, 1T).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Male = 45years

• (LUTS/BPH patients refractory to tamsulosin 0.2mg during 4 weeks)

*All of the following:

• Moderate to severe LUTS : IPSS = 13

• An enlarged prostate (= 20mL, or moderately enlarged)

• Decreased peak flow rate : Qmax =4ml/s, =15mL/s volume voided = 125 mL)

Exclusion Criteria:

• Post voided residual urine = 200mL

• Patients performing catheterization

• Urinary tract infection patients

• Patients taking 5 alpha reductase inhibitor

• Known hypersensitivity to tamsulosin

• History of postural hypotension or syncope

• Hypertension patients treated with other alpha1-blockers

• Patients newly taking anticholinergic medication within 1 month

• Hepatic insufficiency (AST/ALT = 2 times of normal range)

• Renal insufficiency (s-Cr = 2mg/dL)

Study Design

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• tamsulosin
Treatment: tamsulosin 0.2mg, 2T /day Posology: two 0.2 mg tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)
• placebo
(tamsulosin 0.2mg + placebo)/day Posology: two tablet to be taken after an evening meal tamsulosin Tablet is an orally. (smoothly ingested without water)

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the efficacy of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T)in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 12 weeks of treatment in patients with LUTS/BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)		12 weeks of treatment	Yes
Secondary	To evaluate efficacy on maximal flow rate and post-voided residual urine To evaluate efficacy on voiding frequency , nocturia To explore the tolerability and safety		4 weeks and 12 weeks of treatment	Yes