Study to Evaluate the Symptomatic Relief Effects of FLOMAX® in Patients With Signs and Symptoms of Benign Prostatic Hyperplasia

NCT02244242 | Completed Phase 4

• 1 other identifier: 527.16
• Study Type: interventional
• Target: 493
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to evaluate the symptomatic relief afforded by tamsulosin hydrochloride capsules in patients with signs and symptoms of benign prostatic hyperplasia (BPH). Additionally to provide primary care physicians experience with the use of tamsulosin hydrochloride capsules 0.4 mg daily for the treatment of BPH

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change in American Urological Association (AUA) Symptom Score Index by means of a patient self-assessment questionnaire

  up to 45 days

Secondary Outcomes (4)

• Change of AUA Bother Score Index by means of a patient self-assessment questionnaire

  up to 45 days

• Change in BPH Impact Index by means of a patient self-assessment questionnaire

  up to 45 days

• Global Assessment of investigator on 5-point scale

  at 4, 8 and 45 days

• Number of patients with adverse events

  up to 59 days

Study Arms (1)

Tamsulosin hydrochloride

EXPERIMENTAL

modified release capsules

Drug: Tamsulosin hydrochloride

Interventions

Tamsulosin hydrochloride DRUG

Also known as: Flomax®

Tamsulosin hydrochloride

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients (45 years of age or older) diagnosed with BPH who scores at least 13 points on the AUA Symptom Score Index at baseline
• Patients who have a baseline Prostate specific antigen (PSA) of \>= 4.0 ng/ml
• Patients who provide written informed consent prior to participation in the study in accordance with regulatory requirements
• Patients who have been judged by the investigator to be reliable and who have agreed to cooperate with all tests and examinations stipulated in the protocol

You may not qualify if:

• Patients who have previously been diagnosed with prostate cancer
• Patients who have an abnormal Digital rectal examination (DRE) of the prostate gland at baseline other than enlargement (i.e., patients with suspicious areas or nodularity of the gland which may indicate possible prostatic carcinoma are to be excluded)
• Patients who have had previous invasive or non-invasive surgical treatment of the prostate gland
• Patients who have had an episode of acute urinary retention within four weeks of the screening visit
• Patients who have a history or evidence of urethral stricture
• Patients who have had pelvic radiotherapy
• Patients who have a history of chronic prostatitis
• Patients who have a history of neurogenic bladder
• Patients who have had a urinary tract infection (i.e. positive urine culture yielding pathogenic bacteria \>= 10\*\*5 colony forming units per ml or a laboratory report of a urinary tract infection) or symptoms/signs indicative of a urinary tract infection such as: increased white blood cells (WBCs) in the urine (15-30 WBC/high powered field \[hpf\], dysuria, costovertebral tenderness and urinary frequency accompanied by fever within four weeks of baseline
• Patients who have evidence of significant renal dysfunction based upon a serum creatinine greater than two times the upper limit of normal levels established by the central laboratory used in this study
• Patients who have baseline clinical laboratory test results that indicate the following values:
• Hemoglobin: \< 12.0 g/dl
• Leukocytes: \< 3000 mm³
• Liver enzymes: Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Gamma-Glutamyl Transferase (GGT) and alkaline phosphatase): More than two times the upper limit of normal levels established by the central laboratory used in the study
• Patients who have postural symptoms (e.g. lightheadedness, dizziness and fainting occurring with or without a change in Blood Pressure (BP) and/or Heart Rate (HR) within four weeks of baseline

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: July 1, 1998
• Primary Completion: August 1, 1999
• Last Updated: September 19, 2014

Record last verified: 2014-09