Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Difficulty in enrolling particpants)
Sponsor:
Collaborators:
The Cleveland Clinic
University of California, Los Angeles
Information provided by (Responsible Party):
Dr. J. Curtis Nickel, Queen's University
ClinicalTrials.gov Identifier:
NCT01830829
First received: April 10, 2013
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Benign Prostatic Hyperplasia
Chronic Prostatitis
Drug: Jalyn
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Placebo Controlled Trial Evaluating the Efficacy of JALYN in Improving Symptoms in Men Diagnosed With Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Chronic Prostatitis Symptom Index (CPSI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain subdomain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Secondary endpoints will include analyses of CPSI subdomains (pain, urinary, quality of life)

  • IPSS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    International Prostate Symptom Score changes (IPSS)from placebo

  • GRA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Seven point Global Response Assessment (GRA) where responders will be defined as those who report a moderate or marked improvement.

  • Urinary subdomain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Secondary endpoints will include analyses of CPSI subdomains (pain, urinary, quality of life)

  • Quality of Life subdomain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Secondary endpoints will include analyses of CPSI subdomains (pain, urinary, quality of life)


Other Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Examination of AE and SAEs numbers


Enrollment: 1
Study Start Date: April 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jaylyn
Jalyn: dutasteride 0.5 mg/day and tamsulosin 0.4 mg/day combination tablet
Drug: Jalyn
study drug
Other Names:
  • dutasteride 0.5 mg/day
  • tamsulosin 0.4 mg/day combination tablet
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men will be eligible for the study if:

  1. age at least 45 years
  2. report symptoms of discomfort or pain in the pelvic region during at least 3 of the previous 6 months
  3. 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
  4. IPSS score of at least 8 points 5 tenderness on light palpation of the prostate

6. prostate size estimated to be at least 30cc on digital rectal examination

Exclusion Criteria:

Participants are excluded if

  1. prior treatment with dutasteride or finasteride. Alpha blocker therapy within 3 months of randomization.
  2. documented urinary tract infection (>105 colony forming units per ml of a recognized uropathogen)
  3. history of renal failure (or calculated creatinine clearance of < 60 ml/min)
  4. symptomatic genital herpes in the last 3 months.
  5. unilateral orchalgia without pelvic symptoms
  6. a history of active urogenital cancer
  7. active urethral stricture.
  8. 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).
  9. History of alcohol abuse
  10. neurologic disease affecting voiding or the bladder
  11. Psychiatric condition that would make it difficult (in opinion of investigator) for patient to participate in the study
  12. Other acute or chronic medical condition that would make it difficult (in opinion of investigator) for patient to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830829

Locations
Canada, Ontario
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7
Sponsors and Collaborators
Dr. J. Curtis Nickel
The Cleveland Clinic
University of California, Los Angeles
Investigators
Principal Investigator: J. Curtis Nickel, MD FRCSC Queen's University
  More Information

No publications provided

Responsible Party: Dr. J. Curtis Nickel, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01830829     History of Changes
Other Study ID Numbers: JALYN
Study First Received: April 10, 2013
Last Updated: October 21, 2014
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
BPH
CPPS

Additional relevant MeSH terms:
Chronic Disease
Hyperplasia
Pelvic Pain
Prostatic Hyperplasia
Prostatitis
Disease Attributes
Genital Diseases, Male
Pain
Pathologic Processes
Prostatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014