Clinical trial NCT01002417: MCS in the Treatment of Lower Urinary Tract Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Multi-carotenoids
MCS-2
Lower Urinary Tract Symptoms
International prostate symptom scores
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 274
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in International Prostate Symptom Scores
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in I-PSS subscores
timeFrame: 12 weeks
measure: Changes in I-PSS QOL index
timeFrame: 12 weeks
measure: Changes in urine flow rate
timeFrame: 12 weels
measure: Incidence of treatment-emergent adverse events (TEAE)
timeFrame: 12 weeks
measure: Incidence of withdrawals due to TEAEs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Allan J Pantuck, MD, MS, FACS
role: PRINCIPAL_INVESTIGATOR
References: