JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

NCT01830829 | Terminated Phase 3

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

Brief Summary

Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45 associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms and is in part related to prostate enlargement and obstruction. The standard medical therapy for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ specific phenotype) is the third most prevalent prostate disease after prostate cancer and BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of life of patients and economic costs to society. Clinical phenotyping allows for prediction of the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower Urinary Tract Symptoms \[LUTS\] and prostate related phenotypes \[BPH\]). It can be estimated that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN (dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg. BPH and CP/CPPS).

Conditions

Benign Prostatic Hyperplasia; Chronic Prostatitis

Keywords

BPH; CPPS

Outcome Measures

Primary Outcomes (1)

• Chronic Prostatitis Symptom Index (CPSI)

  The primary endpoint will be the mean change in NIH CPSI from baseline in the treated group compared to the mean change in NIH CPSI from baseline in the placebo group at 6 months.

  6 months

Secondary Outcomes (5)

• Pain subdomain

  6 months

• IPSS

  6 months

• GRA

  6 months

• Urinary subdomain

  6 months

• Quality of Life subdomain

  6 months

Other Outcomes (1)

• Safety

  6 months

Study Arms (2)

Jaylyn

EXPERIMENTAL

Jalyn: dutasteride 0.5 mg/day and tamsulosin 0.4 mg/day combination tablet

Drug: Jalyn

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Jalyn DRUG

study drug

Also known as: dutasteride 0.5 mg/day, tamsulosin 0.4 mg/day combination tablet

Jaylyn

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Men will be eligible for the study if:
• age at least 45 years
• report symptoms of discomfort or pain in the pelvic region during at least 3 of the previous 6 months
• total score of at least 12 (out of 43) points on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) at both a screening and randomization visit
• IPSS score of at least 8 points 5 tenderness on light palpation of the prostate
• \. prostate size estimated to be at least 30cc on digital rectal examination

You may not qualify if:

• Participants are excluded if
• prior treatment with dutasteride or finasteride. Alpha blocker therapy within 3 months of randomization.
• documented urinary tract infection (\>105 colony forming units per ml of a recognized uropathogen)
• history of renal failure (or calculated creatinine clearance of \< 60 ml/min)
• symptomatic genital herpes in the last 3 months.
• unilateral orchalgia without pelvic symptoms
• a history of active urogenital cancer
• active urethral stricture.
• surgery of the lower urinary tract (not including simple diagnostic cystoscopy) in the previous 6 months (including TURP, bladder neck incision, bladder tumor resection, urethrotomy).
• History of alcohol abuse
• neurologic disease affecting voiding or the bladder
• Psychiatric condition that would make it difficult (in opinion of investigator) for patient to participate in the study
• Other acute or chronic medical condition that would make it difficult (in opinion of investigator) for patient to participate in the study

Sponsors & Collaborators

• Dr. J. Curtis Nickel: lead
• The Cleveland Clinic: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Centre for Applied Urological Research

Kingston, Ontario, K7L 3J7, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride; Tamsulosin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• J. Curtis Nickel, MD FRCSC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

CA (1)