Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia

NCT00701779 | Completed Phase 4 Results DMC

• 1 other identifier: Siami104907
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; Dutasteride; Tamsulosin

Outcome Measures

Primary Outcomes (5)

• International Prostate Symptom Score

  Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom. Total range is from 0-35. The scores are evaluated as such: 0-7: Mild 8-19: Moderate 20-35: Severe

  12 months

• Peak Flow Rate (QMax)

  Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

  12 months

• Benign Prostate Hyperplasia Impact Index

  Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients. Benign Prostatic Hyperplasia Impact Index asked the following: 1. Over the past month, how much physical discomfort did any urinary problems cause you? (0-3) 2. Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3) 3. Overall, how bothersome has any trouble with urination been during the past month? (0-3) 4. Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13.

  12 months

• Post-void Residual Volume

  Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

  12 months

• Prostate Specific Antigen

  Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

  12 months

Secondary Outcomes (4)

• Health Outcome Measures

  13 months

• Safety and Tolerability

  13 months

• Economic Impact

  13 months

• Number of Participants With a Reduction of AUR and BPH-related Surgery

  13 months

Study Arms (1)

Dutasteride

EXPERIMENTAL

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Also known as: Flomax

Dutasteride

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male ≥50 yrs
• Diagnosed BPH by medical history and physical examination, including a digital rectal examination
• International Prostate Symptom Score ≥12 points at Screening
• Prostate volume ≥30cc (by transrectal ultrasonography; TRUS)
• Total serum Prostate Specific Antigen ≥1.5 ng/mL at Screening
• Maximum flow rate ≥5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
• Able to give written informed consent and comply with study procedures
• Literate in English language with the ability to read, comprehend, and record information on the IPSS, BII, and PPSM questionnaires
• Able to swallow and retain oral medication
• Able to participate for study duration

You may not qualify if:

• History or evidence of prostate cancer
• Previous prostatic surgery or other invasive procedures to treat BPH
• History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Screening. Catheterization (\<10F) is acceptable with no time restriction.
• History of AUR within 3 months prior to Screening
• Post-void residual volume \>250mL (suprapubic ultrasound) at Screening
• Any causes other than BPH, which may in the judgment of the investigator, result in urinary symptoms or changes in flow rate
• History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy
• Use of 5 alpha-reductase inhibitor, any drugs with antiandrogenic properties, or drugs noted for gynecomastia effects, within past 6 months and throughout the study. Previous use of AVODART within 12 months of the baseline or historical TRUS. Chronic use of Metronidazole is prohibited.
• Concurrent use of anabolic steroids
• Use of phytotherapy for BPH within 2 weeks of Screening
• Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening
• Use of any alpha-adrenoreceptor agonists, anticholinergics or cholinergics within 48 hours prior to all uroflowmetry assessments.
• Hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
• Concurrent use of drugs known or thought to interaction with Tamsulosin.
• History of hepatic impairment, abnormal liver function at Screening, History of renal insufficiency, serum creatinine \>1.5 times the upper limit

Sponsors & Collaborators

• Siami, Paul F., M.D.: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Research Institute of Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

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

Results Point of Contact

• Title: Paul F. Siami, MD CPI
• Organization: Deaconess Clinic, Inc.

research.paul.siami@deaconess.com

812-426-9576

Study Officials

• Paul F Siami, MD

  Deaconess Clinic Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Research Institute of Deaconess Clinic

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: September 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 2, 2018
• Results First Posted: January 1, 2015

Record last verified: 2018-11

Locations

US (1)