MCS in the Treatment of Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia Clinical Trial

— MCS_LUTS  

Official title:

An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002417
• Other study ID #: MCS-2-US-a
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 25, 2009
• Last updated: March 1, 2015
• Start date: July 2010
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Health Ever Bio-Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: February 2014
• Est. primary completion date: February 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

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
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
• MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
• Placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.

Locations

Country	Name	City	State
United States	David Geffen School of Medicine at UCLA	Los Angeles	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in International Prostate Symptom Scores		12 weeks	No
Secondary	Changes in I-PSS subscores		12 weeks	No
Secondary	Changes in I-PSS QOL index		12 weeks	No
Secondary	Changes in urine flow rate		12 weels	No
Secondary	Incidence of treatment-emergent adverse events (TEAE)		12 weeks	Yes
Secondary	Incidence of withdrawals due to TEAEs		12 weeks	Yes