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

Health Ever Bio-Tech

Status and phase: Completed; Phase 3

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Drug: MCS-2; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002664

MCS-2-TWN-a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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272 participants in 2 patient groups, including a placebo group

MCS-2

Active Comparator group

Description:

Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks

Treatment:

Drug: MCS-2

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo