A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH). - Tabular View

Tracking Information

First Received Date ^ICMJE

August 22, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00044226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of ML-04A in Subjects With Symptomatic Benign Prostatic Hyperplasia

Brief Summary

Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.

Detailed Description

Patients must be willing to discontinue their current medications being taken for BPH for specified time periods before they become eligible. These include: Proscar, Saw Palmetto, and any "alpha-blocker" drugs.

Patients with high blood pressure must be on an acceptable medication that controls this condition.

Medications for other conditions may disqualify a patient from eligibility.Patients who are diabetic are not eligible for this study.

All patients will, at some time during the study, receive placebo (inactive substance). The study medication is given twice a day in liquid form under the tongue. There is a 33% chance that you would receive placebo for the duration of the study. Neither you nor your doctor will know which treatment you are receiving.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostatic Hyperplasia

Intervention ^ICMJE

Drug: ML-04A

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

350

Completion Date

October 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

Have an enlarged prostate by DRE (digital rectal examination);
Have a diagnosis of BPH;
Have documented symptoms (frequency; urgency; nighttime urination; reduced flow);
Have a documented urinary flow rate as required

Gender

Male

Ages

45 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Martha J. DuRuz-Lynch, BA

414.425.6566

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00044226

Responsible Party

Study ID Numbers ^ICMJE

ML-BPH-01

Study Sponsor ^ICMJE

Milkhaus Laboratory

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Milkhaus Laboratory

Verification Date

August 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP