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NocturiaPhase 4BPHNCT02106182

Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

A Phase 4 study testing Silodosin, Laboratory tests and 3-days voiding diary in people with Nocturia and Benign Prostatic Hyperplasia, run by JW Pharmaceutical at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Nocturia, Benign Prostatic Hyperplasia
What is being tested?
Silodosin, Laboratory tests and 3-days voiding diary
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
6 sitesSouth Korea
Study dates
2 Jan 2014to 1 Aug 2016
Phase
Phase 4
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 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males of at least 50 years of age, with current diagnosis of benign prostatic hyperplasia
  • Symptoms of nocturia evidenced by ≥2 episodes per night in average according to 3-day voiding diary
  • More than total of 8 points on IPSS and 3 points on QoL
  • Able to provide written informed consent and to comply with all study procedures

Who cannot join

  • PSA level > 10 ng/㎖ (except patients who had 4 ng/㎖ < PSA level ≤ 10 ng/㎖ 6 months prior to screening and identified as negative from biopsy)
  • Symptoms of postural hypotension
  • Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
  • Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
  • Severe cardiac disorders or development or diagnosis of vascular disorder (unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, coronary artery bypass graft, etc) 6 months prior to enrollment
  • Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
Show all 18Show fewer
  • Patients with bladder cancer, cystolith or urethral stricture
  • Patients with neurogenic bladder
  • History of acute urinary retention
  • Indwelling catheter or self intermittent catheterization
  • Patients with pyuria 1 month prior to screening
  • History of prostatic cancer
  • History of prostatic surgery
  • Patients with uncontrolled chronic disease
  • Alcoholism or sustained drug dependent abuse 1 year prior to screening
  • Hypersensitivity to α1A-receptor blockers
  • Administration of following drugs within according periods prior to screening - 2 weeks: Antimuscarinic agents (Tolterodine, Trospium, Solifenacin, Fesoterodine, Propiverine, Oxybutynin, Flavoxate, etc), Anticholinesterase agents (Neostigmine methylsulfate, etc), Cholinergic agonists (Bethanechol Cl, etc), Benign prostatic hyperplasia agents (Tamsulosin HCl, Prazosin HCl, Terazosin HCl, Doxazosin mesylate, Silodosin, Naftopidil, etc), Tricyclic antidepressants (Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Quinupramine, etc), 6 months: 5-α-Reductase Inhibitors (Finasteride, Dutasteride)
  • Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • Bucheon St.Mary's Hospital

    Bucheon-si, Gyeonggi-do, 420-818

  • Pusan Natonal University Hospital

    Busan, 602-739

  • Eulji University Hospital

    Daejeon, 302-799

  • Hanyang University Hospital

    Seoul, 133-792

  • Soon Chun Hyang University Hospital

    Seoul, 140-887

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

About this study

Official title: A Multi-center, Prospective, Open-label, Single-arm, 12-weeks, Phase IV Trial to Evaluate the Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia.

Read the detailed description

This study is designed as a multi-center, prospective, open-label and single-arm study. Subjects who are willing to provide written informed consent will be enrolled after screening for eligibility criteria. The subjects will be administered with investigational product for 12 weeks and visit as outpatients for evaluation of safety and efficacy at baseline (visit 2) and 4 weeks (visit 3) and 12 weeks (visit 4) after baseline.

Being tested
Silodosin, Laboratory tests, 3-days voiding diary, 12 weeks
Keywords
Benign prostatic hyperplasia, Nocturia, Silodosin, Thrupas
Medical subject headings
Nocturia, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SilodosinDrug

    Also called Thrupas Cap

  • Laboratory testsOther

    Subject's overall health state will be evaluated by clinical laboratory tests.

    Serum chemistry test: Creatinine, Blood Urea Nitrogen(BUN), Aspartate aminotransferase(AST), Alanine aminotransferase(ALT) Urinalysis: Urine Specific Gravity, Urine pH, Urine Protein, Urine Glucose, Urine Ketone, Urine Bilirubin, Urine Urobilinogen, Urine Nitrite, Urine Occult Blood(OB), Urine Red Blood Cell(RBC), Urine White Blood Cell(WBC) Immunoassay: Prostate Specific Antigen(PSA)

  • 3-days voiding diaryOther

    3-day voiding diaries will be distributed on Visits 1, 2 and 3. Subjects will record incidence of nocturia during 3 days on the diaries within 7 days of Visits 2 (baseline), 3 and 4. The average will be used to confirm the change in incidence of nocturia (at baseline, results from within 1 week from screening may be used but will be excluded for subjects needing wash-out period).

  • 12 weeksOther

Study groups in NCT02106182
Study groupRoleWhat they receive
SilodosinExperimentalSilodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
Receives: Drug: Silodosin; Other: Laboratory tests; Other: 3-days voiding diary; Other: 12 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of nocturia

    Descriptive statistics for incidence of nocturia will be provided for each visit. Paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

Secondary outcomes (9)

  1. Mean change in International Prostate Symptom Score(IPSS) from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  2. Mean change in Quality of Life(QoL) scores from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  3. Mean change in Overactive Bladder Symptom Score(OABSS) from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  4. Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  5. Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  6. Mean change in Question 1 (postvoiding symptoms) of IPSS from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  7. Mean change in Questions 2, 4 and 7 (storage symptoms) from baseline

    Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment.

    Measured: 12 weeks

  8. Ratio of subjects with ≥ 25% decrease in incidence of nocturia

    Measured: 12 weeks

  9. Ratio of subjects with ≥ 25% decrease in IPSS

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2014 (estimated)
  2. Study start2 Jan 2014
  3. Primary completion2 Mar 2016
  4. Study completion1 Aug 2016

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02106182
Sponsor's protocol ID
JW-SDS-406
Acronym
BPH
Status last verified
Mar 2017
First submitted
31 Mar 2014
Last updated
10 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Silodosin, Laboratory tests and 3-days voiding diary in people with Nocturia and Benign Prostatic Hyperplasia, run by JW Pharmaceutical at 6 sites in South Korea.

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 4 inclusion and 18 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: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of nocturia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02106182.

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 10 Mar 2017.

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