A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Lower Urinary Tract Symptoms (LUTS) Clinical Trial

— DELUTS  

Official title:

A Dose-Finding, Multi-Centre, Double-Blind, Randomised, Parallel, Placebo-Controlled Trial to Investigate Efficacy and Safety of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947882
• Other study ID #: FE200486 CS36
• Secondary ID: 2009-012325-1110
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2009
• Last updated: May 13, 2015
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaCanada: Ethics Review CommitteeItaly: The Italian Medicines AgencyItaly: Ministry of HealthItaly: National Bioethics CommitteeCzech Republic: State Institute for Drug ControlCzech Republic: Ethics CommitteePoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent obtained before any trial-related activity is performed

• Men, aged 50 or older

• Clinical signs and symptoms of BPH for =6 months

• Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) =13

• An IPSS QoL score of =3 at screening

• Prostate specific antigen (PSA) at screening =10 ng/mL (responsibility of the Investigator to rule out prostate cancer when PSA is >4 ng/mL, except in the USA where patients with a PSA >4 and =10 ng/mL should undergo a prostatic biopsy or have a negative prostatic biopsy within 12 months prior to participation in the trial)

• Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening

Exclusion Criteria:

• Post void residual volume (PVR) >250 mL

• Stone in the bladder or urethra causing symptoms

• Acute or chronic prostatitis

• Interstitial cystitis / painful bladder syndrome

• Acute or recurrent urinary tract infections

• History of acute urinary retention (AUR)

• Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2

• Clinical evidence of any of the following urinary tract conditions:

1. Mullerian duct cysts

2. Atonic, decompensated, or hypocontractile bladder

3. Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation)

• History of any of the following pelvic conditions:

1. Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery

2. Pelvic radiotherapy

3. Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies

4. Lower tract malignancy or trauma

• Clinically significant microscopic haematuria at screening

• History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at screening

• Systolic blood pressure >180 or <90 mmHg or diastolic blood pressure >110 or <50 mmHg at screening or malignant hypertension

• Any causes other than BPH, which may affect evaluation of symptoms of urine flow (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator

• Use of any prohibited therapies

• Elevated liver function tests at screening:

1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) >2 times the upper limit of normal

2. Total bilirubin >1.5 times the upper limit of normal

• QTc interval on the screening ECG >450 ms, or a family history of long QT syndrome

• Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator

• Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin

• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema

• Mental incapacity or language barrier precluding adequate understanding or co-operation

• History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening

• Hypersensitivity towards any component of the investigational medicinal product (IMP)

• Previous participation in any degarelix trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms (LUTS)
• Prostatic Hyperplasia

Intervention

Drug:
• Placebo
Mannitol 50 mg/mL solution
• Degarelix 10 mg
10 mg degarelix, 40 mg/mL solution
• Degarelix 20 mg
20 mg degarelix, 40 mg/mL solution
• Degarelix 30 mg
30 mg degarelix, 40 mg/mL solution

Locations

Country	Name	City	State
Belgium	Middelheim Antwerp	Antwerpen
Belgium	UZ Brussel	Brussels
Canada	Male/Female Health and Research Centre	Barrie	Ontario
Canada	Bramalea Medical Centre	Brampton	Ontario
Canada	Brandford Urology Research	Brantford	Ontario
Canada	Guelp Urology	Guelph	Ontario
Canada	Centre for Applied Urological Research	Kingston	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Investigational Site	North Bay	Ontario
Canada	Female/Male Health Centres	Oakville	Ontario
Canada	Mahoney Medicine Professional Corporation	Ottawa	Ontario
Canada	Todd Webster Ontario Inc	Owen Sound	Ontario
Canada	Ultra-Med Inc	Point-Claire	Quebec
Canada	Anthony Skehan Medicine Professional Corporation	Thunder Bay	Ontario
Canada	The Male Health Centre	Toronto	Ontario
Canada	Can-Med Clinical Research Inc	Victoria	British Columbia
Canada	Dr Steinhoff Clinical Research	Victoria	British Columbia
Czech Republic	Urologie, Male namesti 1783	Benesov
Czech Republic	Urocentrum Brno, Purkynova 35e	Brno
Czech Republic	Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220	Hradec Králové
Czech Republic	Urologicka ambulance, Litomerice (Halek)	Litomerice
Czech Republic	Slezska nemocnice, prospevkova organizace, Urologicke oddeleni	Opava
Czech Republic	Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289	Praha
Czech Republic	Urocentrum, Karlovo namesti 3	Praha
Czech Republic	Urologica ambulance, Praha 10	Praha
Czech Republic	Ústecké urocentrum, Ústi nad Labem (Liehne)	Ústi nad Labem
Italy	Urologia, A.O. San Giuseppe Moscati, Avellino	Avellino
Italy	Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco	Milano
Italy	Unità Operativa di Urologia, Ospedale San Raffaele	Milano
Poland	Akademia Medyczna w Gdansku	Gdansk
Poland	Publiczny Specjalistyczny ZOZ	Inowroclaw
Poland	Samodzielny Publiczny Szpital Kliniczny nr.1	Zabrze
United States	South Florida Medical Research	Aventura	Florida
United States	Northwestern University	Chicago	Illinois
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Urology Associates , PC	Englewood	Colorado
United States	Urology Centers of Alabama, PC	Homewood	Alabama
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Weill Cornell Medical College New York Presbyterian	New York	New York
United States	California Professional Research	Newport Beach	California
United States	Winter Park Urology Associates	Orlando	Florida
United States	Hudson Valley Urology, PC	Poughkeepsie	New York
United States	Pinellas Urology Inc	St Petersburg	Florida
United States	Florida Urology Partners	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czech Republic,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in International Prostate Symptom Score (IPSS)	This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.; The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and "5" corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score.	From Baseline to Month 3 after Dosing	No
Secondary	Mean Change in IPSS	This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.	From Baseline to Month 4, Month 5 and Month 6 after Dosing	No
Secondary	Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS	A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.	At Month 3, Month 4, Month 5 and Month 6 after Dosing	No
Secondary	Mean Percentage Change in Total Prostate Volume (TPV)	TPV was measured directly by standardised trans-rectal ultrasound (TRUS).	From Baseline to Month 3 and Month 6 after Dosing	No
Secondary	Mean Change in Maximum Urinary Flow (Qmax)	Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).	From Baseline to Month 3 and Month 6 after Dosing	No