MCS in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)

Health Ever Bio-Tech

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Drug: MCS-2 15 mg/day; Drug: Placebo; Drug: MCS-2 30 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002417

MCS-2-US-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

This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.

Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2.

Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

Enrollment: 274 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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274 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Both the phase 2b and phase 3 parts of the study have the placebo arm.

Treatment:

Drug: Placebo

MCS-2 15 mg/day

Active Comparator group

Description:

For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.

Treatment:

Drug: MCS-2 30 mg/day

Drug: MCS-2 15 mg/day

MCS-2 30 mg/day

Active Comparator group

Description:

For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.

Treatment:

Drug: MCS-2 30 mg/day

Drug: MCS-2 15 mg/day