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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Drug: MCS-2; Drug: Placebo

• Registration Number: NCT01002664
• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-25
• Study First Posted: 2009-10-27
• Study Start: 2010-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 272

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCS-2	MCS-2	Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Placebo	Placebo	Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in total International Prostate Symptom Scores (I-PSS)	12 weeks	Changes in total International Prostate Symptom Scores (I-PSS)

Secondary Outcome Measures

Name	Time	Method
Changes in I-PSS quality of life index	12 weels	Changes in I-PSS quality of life index
Changes in I-PSS subscores	12 weeks	Changes in I-PSS subscores
Changes in urinary peak flow rate	12 weeks	Changes in urinary peak flow rate
Incidence of treatment-emergent adverse events	12 weeks	Incidence of treatment-emergent adverse events
Incidence of withdrawals due to treatment-emergent adverse events	12 weeks	Incidence of withdrawals due to treatment-emergent adverse events

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan