Efficacy and Safety of MCS-2 in the Treatment of Lower Ur... | NCT01002664

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

NCT01002664

Sponsor

Health Ever Bio-Tech Co., Ltd.

Status

Completed

Last Update Posted

Aug 2, 2018Actual

Enrollment

272Actual

Phase

Phase 3

Conditions

Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia

Interventions

MCS-2
Placebo

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Oct 20, 2009

First Submission Date that Met QC Criteria

Oct 25, 2009

First Posted Date

Oct 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

272Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MCS-2	Active Comparator	Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks	Drug: MCS-2
Placebo	Placebo Comparator	Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MCS-2	Drug	30 mg/day (two 15 mg capsules) Qd for 12 weeks	MCS-2	MUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in total International Prostate Symptom Scores (I-PSS)	Changes in total International Prostate Symptom Scores (I-PSS)	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in I-PSS subscores	Changes in I-PSS subscores	12 weeks
Changes in I-PSS quality of life index	Changes in I-PSS quality of life index

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yeong-Shiau Pu, MD PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		10002	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 13, 2023
Reset	Dec 29, 2023
Release	Jun 10, 2024
Reset	Jul 1, 2024

Submission Tracking

Estimated Results First Submitted Date

Dec 13, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 13, 2023			Dec 29, 2023
Jun 10, 2024

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011469	Prostatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided