Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)

NCT ID: NCT00939120

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-09-30

Brief Summary

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).

Detailed Description

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tolterodine ER 4mg

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Group Type: EXPERIMENTAL

Tolterodine ER 4mg

Intervention Type: DRUG

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Pre-randomization Dutasteride

Intervention Type: DRUG

All participants were on Dutasteride 0.5mg orally once daily prior to randomization.

placebo

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Pre-randomization Dutasteride

Intervention Type: DRUG

All participants were on Dutasteride 0.5mg orally once daily prior to randomization.

Interventions

Tolterodine ER 4mg

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Intervention Type: DRUG

Placebo

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Intervention Type: DRUG

Pre-randomization Dutasteride

All participants were on Dutasteride 0.5mg orally once daily prior to randomization.

Intervention Type: DRUG

Other Intervention Names

Detrol LA

Eligibility Criteria

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

1. Subjects who understand and speak English and are able to comply with the protocol, complete the diaries, and other study tools

2. Subject has provided written informed consent and HIPAA authorization

3. Ambulatory male subjects ≥ 50 years of age

4. Able to use the toilet without difficulty

5. History of LUTS due to BPE, as diagnosed by history as well as digital rectal exam (DRE), for ≥ 3 months suitable for medical therapy with 5-ARI in combination with antimuscarinic drugs

6. Prostate volume (PV) ≥ 30 cc as measured by transrectal ultrasound (TRUS)

7. International prostate symptoms score (IPSS) ≥12

8. Post Void Residual Volume < 150 mL at baseline

9. Uroflowmetry-Qmax > 5 mL/sec and ≤ 15 mL/sec

10. Prostate specific antigen (PSA) ≥ 1.5 ng/ml and in normal age-adjusted range. For those subjects with an elevated age-adjusted PSA, it is the responsibility of the investigator to take standard of care measures to assure reasonable absence of prostate cancer

11. Have an average of ≥ 8 micturitions per 24 hrs

12. Have an average of 2 episodes of urgency per 24 hrs (defined as those with the Urinary Sensation Scale rating of 3 or more)

14. A known diagnosis of prostate cancer.

15. A known diagnosis of bladder cancer within 5 years of screening. Those patients with history of non-muscle invasive bladder cancer who have not had a recurrence in the past 5 years are eligible to screen for this study and must maintain continued adequate bladder cancer screening at the discretion of the Investigator

16. Renal or hepatic impairment defined as 2.5 x upper limit of normal. Some isolated abnormalities would be left at the discretion of the investigator with always keeping in mind to not pose a hazard to the patient.

17. PSA > 10 ng/mL (if the PSA is greater than 4 ng/mL and less than or equal to 10 ng/mL, subjects may be included at the discretion of the Investigator if the PSA has been stable and the patient has had a prostate biopsy showing no evidence of prostate cancer)

18. Known or suspected hypersensitivity to dutasteride or tolterodine ER .

19. Participation in a clinical trial involving an investigational drug, within 30 days prior to enrollment.

20. History of diagnosed gastrointestinal obstruction disease.

21. Myocardial infarction within the past 8 weeks.

22. Known or suspected drug and/or alcohol abuse.

23. Any clinical condition, which, in the opinion of the Investigator, would not allow safe completion of the study.

Exclusion Criteria

1. Concurrent use of 5-ARI therapy within the past 3 months

2. Concurrent use of alpha blockers within the past 2 weeks

3. Concurrent use of antimuscarinics within the past 4 weeks

4. Concurrent use of Phosphodiesterase type 5 (PDE-5) inhibitors on a daily basis

5. Evidence of chronic inflammation such as interstitial cystitis and bladder stones.

6. Evidence of untreated urethral stricture disease

7. Uncontrolled narrow angle glaucoma

8. Increased post-void residual volume (PVR) defined as PVR > 150 mL

9. Uroflowmetry-Qmax ≤ 5 mL/sec

10. Acute urinary tract infection (UTI). These subjects may be treated and re-screened

11. Acute urinary retention (AUR) requiring catheter within the last 3 months

12. Previous or planned transurethral resection of the prostate (TURP)

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Siami, Paul F., M.D.

OTHER

Sponsor Role: lead

Responsible Party

Paul F. Siami, MD

Medical Director, Deaconess Clinic Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul F Siami, MD

Role: PRINCIPAL_INVESTIGATOR

Deaconess Clinic Research Institute

Locations

Deaconess Clinic Gateway Health Center

Newburgh, Indiana, United States

Countries

United States

Other Identifiers

110983

Identifier Type: -

Identifier Source: org_study_id