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Sponsors and Collaborators: |
Siami, Paul F., M.D. eraClinical GlaxoSmithKline Pfizer |
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Information provided by: | Siami, Paul F., M.D. |
ClinicalTrials.gov Identifier: | NCT00939120 |
This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder (OAB) symptoms).
Condition | Intervention | Phase |
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Lower Urinary Tract Symptoms |
Drug: dutasteride 0.5 mg, used with tolterodine ER 4mg or placebo Drug: dutasteride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency |
Estimated Enrollment: | 60 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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dutasteride 0.5 mg: Active Comparator
open-label dutasteride 0.5 mg once daily for 6 months
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Drug: dutasteride
open-label dutasteride 0.5 mg once daily for 6 months
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dutasteride 0.5 mg, tolterodine ER 4 mg, placebo: Experimental
dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo
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Drug: dutasteride 0.5 mg, used with tolterodine ER 4mg or placebo
dutasteride 0.5 mg orally once daily for six months, followed by randomization in a 1:1 ratio into two parallel groups of
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Men who are treated with an alpha blocker (AB) or 5-alpha reductase inhibitor (5-ARI) for benign prostatic enlargement (BPE) and lower urinary tract symptoms (LUTS) often have symptoms including urinary frequency and urgency. ABs and 5-ARIs may improve the obstructive voiding symptoms but not necessarily the storage symptoms.
This study will evaluate the safety and efficacy of dutasteride 0.5 mg once daily for 6 months in an open label fashion. Those patients who continue to report storage urinary symptoms, will be randomized to receive dutasteride 0.5 mg once daily for an additional one year together with double-blind tolterodine ER 4 mg or matched tolterodine ER placebo once daily.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
This subject population will consist of males ≥ 50 years of age who have lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) for a minimum of 3 months
Inclusion criteria at screening:
Exclusion Criteria:
Contact: Jennifer L Claymier, RN, BS, CRC | 812-426-9307 | jennifer_claymier@deaconess.com |
Contact: Donna J Racine | 812-426-9215 | donna_racine@deaconess.com |
United States, Indiana | |
Deaconess Clinic Gateway Health Center | Recruiting |
Newburgh, Indiana, United States, 47630 | |
Contact: Amy Willis, RN 812-492-5079 amy_willis@deaconess.com | |
Principal Investigator: Paul F Siami, MD |
Responsible Party: | Deaconess Clinic Research Institute ( Paul F. Siami, MD ) |
Study ID Numbers: | 110983 |
Study First Received: | June 12, 2009 |
Last Updated: | July 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00939120 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lower Urinary Tract Symptoms LUTS dutasteride tolterodine ER |
Muscarinic Antagonists Dutasteride Neurotransmitter Agents |
Cholinergic Antagonists Cholinergic Agents Tolterodine |
Muscarinic Antagonists Dutasteride Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists |
Physiological Effects of Drugs Enzyme Inhibitors Cholinergic Agents Pharmacologic Actions Tolterodine |