Lower Urinary Tract SymptomsPhase 3NCT02003742
Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH
A Phase 3 study testing NX-1207 and Tamsulosin in people with Lower Urinary Tract Symptoms, run by RECORDATI GROUP at 5 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- NX-1207 and Tamsulosin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2013to 29 Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 11Show fewer
- 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).
Who cannot join
- 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;
Show all 22Show fewer
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Germany1 site
Klinikum der Ludwig-Maximilians-universität München
Munich, 81377
Italy1 site
Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele
Milan, 20132
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Sheffield, S10 2JF
About this study
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
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.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- NX-1207, Tamsulosin
- Keywords
- LUTS, BPH
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-1207Drug
Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207
TamsulosinDrug
1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD
| Study group | Role | What they receive |
|---|---|---|
| NX-1207 | Experimental | 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. Receives: Drug: NX-1207 |
| Comparator | Active 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 Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total IPSS score.
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.
Measured: 12 months
Secondary outcomes (6)
Effects on Lower Urinary Tract Symptoms
- 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
Measured: 1,3,6,9 and 12 months
Effects on Quality of Life (QoL) due to urinary symptoms
- Change from baseline in IPSS subscore Quality of Life due to urinary symptoms;
- Change from baseline in BPH Impact Index
Measured: 1,3,6,9 and 12 months
Effects on general health related Quality of Life
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.
Measured: 12 months
Patient's global assessment of treatment
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.
Measured: 12 months
Effects on maximum urinary flow rate (Qmax)
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.
Measured: 3,6,9 and 12 months
Effects on prostate volume
The change from baseline in TRUS assessed prostate volume at 3 and 12 months (or in case of early termination) will be considered.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completion29 Jan 2015
- Study completion29 Jan 2015
Why it stopped: The study was stopped because in two other clinical studies the drug was not superior in comparison with placebo
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003742
- Sponsor's protocol ID
- NX1207-IT-CL 0414
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02003742
- Acronym / sponsor ID
- NX1207-IT-CL 0414
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- LUTS, BPH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because in two other clinical studies the drug was not superior in comparison with placebo
- Enrolment
- 104 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- 29 Jan 2015 (actual)
- Study completion
- 29 Jan 2015 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NX-1207 | Experimental | Drug: NX-1207Subjects 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. |
| Comparator | Active comparator | Drug: TamsulosinSubjects 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (22 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NX-1207Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207 | Drug | NX-1207 |
| Tamsulosin1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD | Drug | Comparator |
Primary outcome
Change from baseline in the total IPSS score.
Time frame: 12 months
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.
6 secondary outcomes
Effects on Lower Urinary Tract Symptoms
Time frame: 1,3,6,9 and 12 months
Effects on Quality of Life (QoL) due to urinary symptoms
Time frame: 1,3,6,9 and 12 months
Effects on general health related Quality of Life
Time frame: 12 months
Patient's global assessment of treatment
Time frame: 12 months
Effects on maximum urinary flow rate (Qmax)
Time frame: 3,6,9 and 12 months
Effects on prostate volume
Time frame: 3 and 12 months
Results and safety
The study was stopped early (reason given: The study was stopped because in two other clinical studies the drug was not superior in comparison with placebo). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
Related trials for Lower Urinary Tract Symptoms
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NX-1207 and Tamsulosin in people with Lower Urinary Tract Symptoms, run by RECORDATI GROUP at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Italy, Poland, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped because in two other clinical studies the drug was not superior in comparison with placebo). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total IPSS score. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.