Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Recordati Industria Chimica e Farmaceutica S.p.A.
Sponsor:
Information provided by (Responsible Party):
Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier:
NCT02003742
First received: December 2, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

The purpose of the this international, multicenter, randomised, single-blind, parallel group, Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.


Condition Intervention Phase
Lower Urinary Tract Symptoms
Drug: NX-1207
Drug: Tamsulosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Single Transrectal Ultrasound(TRUS)-Guided Intraprostatic Injection of NX-1207 in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Phase III European Study

Resource links provided by NLM:


Further study details as provided by Recordati Industria Chimica e Farmaceutica S.p.A.:

Primary Outcome Measures:
  • Change from baseline in the total IPSS score. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    The primary efficacy parameter is the change from baseline in the total score (Questions 1 to 7) of the IPSS at 12 months.

    The IPSS questionnaire will be filled by the subjects in blind conditions and will be reviewed by the investigators for its completeness. Validated local translations of the IPSS questionnaire will be used in each country.



Secondary Outcome Measures:
  • Effects on Lower Urinary Tract Symptoms [ Time Frame: 1,3,6,9 and 12 months ] [ Designated as safety issue: No ]
    • Change from baseline in IPSS total score at 1, 3, 6 and 9 months;
    • Change from baseline in IPSS subscores for storage symptoms;
    • Change from baseline in IPSS subscores for voiding symptoms;
    • Response rate by IPSS

  • Effects on Quality of Life (QoL) due to urinary symptoms [ Time Frame: 1,3,6,9 and 12 months ] [ Designated as safety issue: No ]
    • Change from baseline in IPSS subscore Quality of Life due to urinary symptoms;
    • Change from baseline in BPH Impact Index

  • Effects on general health related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    The change from baseline in the EQ-5D-5L questionnaire at 12 months or in case of early termination will be considered.

    The EQ-5D-5L questionnaire is a standardised validated instrument for use as a measure of health outcome.


  • Patient's global assessment of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    A patient-rated global assessment of treatment benefit, satisfaction and willingness to continue will be performed at 12 months (or in case of early termination) by using the BSW questionnaire.

    The BSW is a validated questionnaire that consists of three, single-item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.


  • Effects on maximum urinary flow rate (Qmax) [ Time Frame: 3,6,9 and 12 months ] [ Designated as safety issue: No ]
    To evaluate the effect on urinary flow, the change from baseline in maximum urinary flow (Qmax) at 3, 6, 9, 12 months will be considered. The same validated device and procedure will be used in all centres and a blinded centralized reading is foreseen.

  • Effects on prostate volume [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    The change from baseline in TRUS assessed prostate volume at 3 and 12 months (or in case of early termination) will be considered.


Other Outcome Measures:
  • Long term follow-up evaluation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    The following data will be evaluated:

    • Percentage of subjects requiring medical therapy, MIST, TURP or surgery for LUTS/BPH and time to treatment failure;
    • Change from baseline in the total score of the IPSS;
    • Change from baseline in QoL due to urinary symptoms
    • Change from baseline in general health-related QoL (EQ-5D-5L);
    • SAEs and episodes of acute urinary retention.


Estimated Enrollment: 340
Study Start Date: September 2013
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NX-1207
Subjects randomised to the NX-1207 group will receive a single NX-1207 (2.5 mg) TRUS-guided intraprostatic injection (under antibiotic prophylaxis), followed by a placebo QD oral treatment for 12 months.
Drug: NX-1207
Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207
Active Comparator: Comparator
Subjects randomised to the comparative arm will undergo TRUS only (under placebo prophylaxis) and will continue the tamsulosin 0.4 mg QD oral treatment for 12 months
Drug: Tamsulosin
1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD

  Eligibility

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

Inclusion Criteria:

  • Signed informed consent;
  • Age 45 or older;
  • Medical history of LUTS/BPH
  • Use of a marketed α-blocker for LUTS/BPH in the last 8 weeks;
  • LUTS/BPH not adequately controlled by medical therapy with α-blockers;
  • Presence of moderate-severe LUTS (IPSS ≥ 15) at screening and at baseline (after a 4 week run-in period with tamsulosin 0.4 mg QD);
  • Prostate Volume ≥ 30 mL and ≤ 70 mL (as assessed by TRUS);
  • Qmax < 15 mL/sec based on a minimum void of 125 mL;
  • Agree not to use any other approved or experimental BPH or overactive bladder (OAB) medication anytime during the core study;
  • Agree to perform follow-up visits even in case of oral treatment discontinuation before study end;
  • Satisfactory compliance to run-in medication at Visit 2 (baseline).

Exclusion Criteria:

  • Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment;
  • Acute or chronic prostatitis or suspected prostatitis including chronic pain, intermittent pain or abnormal sensation in the penis, testis, anal or pelvic area in the past 12 months;
  • PSA ≥ 10 ng/mL. In case of a PSA between 4.0 and 10.0 ng/mL, prostate cancer must have been ruled out to the satisfaction of the clinical Investigator by an historical biopsy;
  • Prostate or bladder cancer, history of pelvic irradiation;
  • Active or recurrent urinary tract infections (more than 1 episode in the last 12 months);
  • History of neurogenic bladder or LUTS secondary to neurologic disease;
  • Use of self-catheterization for urinary retention;
  • Post-void residual urine volume > 200 mL;
  • Haematuria which has not been appropriately evaluated to determine safe subject participation;
  • Renal insufficiency (serum creatinine >2.0 mg/dL);
  • Liver insufficiency (any liver function tests [LFTs]>2x upper limit of normal [ULN]);
  • Poorly controlled diabetes (type 1 or type 2), as determined by HbA1c >6% and/or glycosuria;
  • Any bleeding disorder such as haemophilia, clotting factor(s) deficiency or bleeding diathesis;
  • Immunosuppressive disorders, such as Human Immunodeficiency (HIV) Virus, Acquired Immune Deficiency Syndrome (AIDS), lymphoproliferative disorders;
  • Acute or chronic intestinal disease, such as ulcerative colitis, Crohn's disease, acute gastroenteritis in the run-in period; acute painful perianal disorder;
  • Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, Percutaneous Transluminal Coronary Angioplasty (PTCA), congestive heart failure NYHA Class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
  • Any condition that would interfere with the subject's ability to provide informed consent, to comply with study instructions, or that might confound the interpretation of the study results, such as dementia, psychosis, manic depressive disorder, post-traumatic stress disorder, stroke, Alzheimer's, depression, psychiatric illness, history or current evidence of drug or alcohol abuse within the last 12 months etc.;
  • Participation in a study of any investigational drug or device within the previous 6 months;
  • Hypersensitivity or contraindication to tamsulosin use;
  • Use of prohibited medications that could endanger subjects performing the intraprostatic injection or that could interfere with the evaluation of study parameters;
  • Men planning to have children in the future;
  • Any other condition that may interfere with the study or endanger the subject.
  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: NCT02003742

Contacts
Contact: Federica Miotto +39.02.48787183 miotto.f@recordati.it

Locations
Germany
Klinikum der Ludwig-Maximilians-universität München Recruiting
Munich, Germany, 81377
Contact: Christian GRATZKE, MD         
Principal Investigator: Christian GRATZKE, MD         
Italy
Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele Recruiting
Milan, Italy, 20132
Principal Investigator: Francesco Montorsi, MD         
Poland
Niepubliczny Zaklad Opieki Zdrowotnej Specjalista Recruiting
Kutno, Poland, 99-300
Contact: Piotr Humanski, Dr.         
Principal Investigator: Piotr Humanski, MD         
Spain
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Carlos HERNÁNDEZ FERNÁNDEZ, MD         
Principal Investigator: Carlos HERNÁNDEZ FERNÁNDEZ, MD         
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Christopher Re Chapple, BSc MD    +44 07768902102    c.r.chapple@sheffield.ac.uk   
Contact: Susannah Hulton, RGN    +44 0114 2711870    susannah.hulton@sth.nhs.uk   
Principal Investigator: Christopher Re Chapple, Bsc MD         
Sponsors and Collaborators
Recordati Industria Chimica e Farmaceutica S.p.A.
  More Information

No publications provided

Responsible Party: Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier: NCT02003742     History of Changes
Other Study ID Numbers: NX1207-IT-CL 0414
Study First Received: December 2, 2013
Last Updated: December 2, 2013
Health Authority: Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Recordati Industria Chimica e Farmaceutica S.p.A.:
LUTS
BPH

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014