Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia Clinical Trial

— MCS_LUTS  

Official title:

A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002664
• Other study ID #: MCS-2-TWN-a
• Status: Completed
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: July 2018
• Source: Health Ever Bio-Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Description:

Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age ? 40 years old.

• Not being treated for BPH or LUTS.

• PSA ? 4 ng/ml and no pathologically-proven prostate cancer.

• I-PSS = 10

• No known malignancy

• AST/ALT ? 3X UNL.

• Creatinine ? 3X UNL.

• Subjects who sign the informed consent form.

Exclusion Criteria:

• Subjects' LUTS are not BPH-related

• Have been treated with pelvis irradiation or pelvic surgery.

• Plan to undergo any invasive procedures within the study period.

• Active infection or inflammation.

• Considered ineligible by the investigators.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• MCS-2
30 mg/day (two 15 mg capsules) Qd for 12 weeks
• Placebo
2 soft-gel placebo capsules Qd for 12 weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Health Ever Bio-Tech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total International Prostate Symptom Scores (I-PSS)	Changes in total International Prostate Symptom Scores (I-PSS)	12 weeks
Secondary	Changes in I-PSS subscores	Changes in I-PSS subscores	12 weeks
Secondary	Changes in I-PSS quality of life index	Changes in I-PSS quality of life index	12 weels
Secondary	Changes in urinary peak flow rate	Changes in urinary peak flow rate	12 weeks
Secondary	Incidence of treatment-emergent adverse events	Incidence of treatment-emergent adverse events	12 weeks
Secondary	Incidence of withdrawals due to treatment-emergent adverse events	Incidence of withdrawals due to treatment-emergent adverse events	12 weeks