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NCT Number: NCT01002664

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

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MCS-2

Drug

30 mg/day (two 15 mg capsules) Qd for 12 weeks

Other names: MUS

Placebo

Drug

2 soft-gel placebo capsules Qd for 12 weeks

Other names: MCS Matching Placebo

Primary outcomes

  1. Changes in total International Prostate Symptom Scores (I-PSS)

    Time frame: 12 weeks

    Changes in total International Prostate Symptom Scores (I-PSS)

Secondary outcomes

  1. Changes in I-PSS subscores

    Time frame: 12 weeks

    Changes in I-PSS subscores

  2. Changes in I-PSS quality of life index

    Time frame: 12 weels

    Changes in I-PSS quality of life index

  3. Changes in urinary peak flow rate

    Time frame: 12 weeks

    Changes in urinary peak flow rate

  4. Incidence of treatment-emergent adverse events

    Time frame: 12 weeks

    Incidence of treatment-emergent adverse events

  5. Incidence of withdrawals due to treatment-emergent adverse events

    Time frame: 12 weeks

    Incidence of withdrawals due to treatment-emergent adverse events

Sponsors and collaborators

Lead sponsor

Health Ever Bio-Tech Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects

Acronym: MCS_LUTS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 27, 2009
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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