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The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy (DA8159_EDP_IIT)

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ClinicalTrials.gov Identifier: NCT03142542
Recruitment Status : Unknown
Verified May 2017 by Seong Soo Jeon, Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Seong Soo Jeon, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE May 5, 2017
Last Update Posted Date May 5, 2017
Estimated Study Start Date  ICMJE May 2017
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
The proportion of patients who has IIEF-EF score ≥22 [ Time Frame: at 32 weeks ]
The IIEF-EF score is International Index of Erectile Function - Erectile Function. The Questionaire is composed of 6 questions.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Safety evaulation: Occurrence of any adverse events [ Time Frame: for 32 weeks ]
    The AE is evaluated for grade, intensity, relationship by protocol definition
  • Safety evaluation: Systolic and diastolic blood pressure [ Time Frame: for 32 weeks ]
    by Physical exam, mmHg
  • Safety evaluation: 12-lead ECG [ Time Frame: for 32 weeks ]
    ECG test
  • Safety evaluation: Number of Participants With Abnormal Laboratory Values [ Time Frame: for 32 weeks ]
    Blood and urine test
  • Safety evaluation:pulse rate [ Time Frame: for 32 weeks ]
    by Physical exam, beats per minute
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Udenafil in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial to Evaluate the Efficacy and Safety of Udenafil Dosed Once a Day in Patients With Erectile Dysfunction After Bilateral Nerve-sparing Radical Prostatectomy
Brief Summary This study evaluates the efficacy and safety of Udenafil dosed once a day in patients with erectile dysfunction after bilateral nerve-sparing radical prostatectomy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer With Radical Prostatectomy
Intervention  ICMJE
  • Drug: ZYDENA TAB.75mg(Udenafil 75mg)
    ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks
  • Drug: Placebo Oral Tablet
    Placebo Oral Tablet: by mouth, Once daily, for 32 weeks
Study Arms  ICMJE
  • Experimental: Udenafil 75mg
    Drug: Udenafil 75mg by mouth, once daily, for 32 weeks
    Intervention: Drug: ZYDENA TAB.75mg(Udenafil 75mg)
  • Placebo Comparator: Placebo
    Drug: placebo by mouth, once daily, for 32 weeks
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 4, 2017)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male aged 20 or over 20 years and not more than 70 years who underwent bilateral nerve-sparing radical prostatectomy due to prostate cancer without metastasis
  • IIEF-EF score ≥22 at 1-8 weeks before bilateral nerve-sparing radical prostatectomy, and IIEF-EF ≤16 at screening visit
  • Presence of sexual partner from 8 weeks before bilateral nerve-sparing radical prostatectomy, and had planned to keep it during the trial
  • Agreed not to use any other erectile dysfunction medication (including both generic and specialty medicines) and other erectile dysfunction therapies during the trial period.
  • Patient agrees to voluntary participation and follow the instructions carefully, after fully hearing and understanding the details of this clinical trial

Exclusion Criteria:

  • Patient who needs additional treatment in addition to bilateral nerve- sparing radical prostatectomy
  • Use Inhibitors of PDE-5 (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and Generic Medicines) or autologous injections of vasodilators or other erectile dysfunction therapies for erectile dysfunction within the first 8 weeks of bilateral nerve-sparing radical prostatectomy
  • If there is an uncontrolled diabetes (HbA1C> 12%) at Visit 1
  • If there is proliferative diabetic retinopathy at Visit 1
  • If there is a history of CABG surgery, stroke, unstable angina, myocardial infarction, life-threatening arrhythmia, or heart failure within 6 months before the screening visit
  • History of spinal cord injury, non nerve-sparing radical prostatectomy or radical pelvic surgery
  • Hypotension below 90 / 50mmHg or uncontrolled hypertension above 170 / 100mmHg
  • Penis anatomic abnormalities (severe penile fibrosis, Peyronie's disease, etc.)
  • Presence of serious disability such as malignant tumor, lung, blood, endocrine system in Visit 1
  • Patient who have active hepatitis B or C or who are infected with HIV virus
  • Patient who have genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency, glucose-galactose uptake disorder
  • Patient who have hyperprolactinemia or hypothyroidism

    • Serum AST and ALT are three times higher than normal upper limit
    • Serum Creatinine ≥ 2.5 mg / dl
  • Patient who have retinitis pigmentosa
  • Patient who have blood disease (sickle cell disease, multiple myeloma, leukemia) or bleeding disorder that can cause priapism
  • Patient with congenital QT prolongation syndrome or those taking a drug that increases QT interval
  • If the examiner considers that he / she is not suitable for participation in clinical trials, such as mental disorder or persistent abuse of medication
  • Patient who is taking Nitrate / Nitric oxide (NO) donor (Nitroglycerin, Sodium nitroprusside, Isosorbide mononitrate / dinitrate, Amyl nitrate / nitrite, etc.)
  • Patient who is taking Guanylate Cyclase stimulator (such as Riociguat)
  • Patient who is taking warfarin
  • Patient who is taking medications or foods that affect CYP3A4 metabolism

    • Metabolic inhibitors: Antibacterials (Erythromycin, etc.), Antifungals (Itraconazole, etc.), Antivirals (Ritonavir, Saquinavir, Amprenavir, Indinavir, Nelfinavir, etc.), H2 receptor antagonist (Cimetidine, etc), or grapefruit juice
    • Metabolic inducers: Dexamethasone, Rifampicin, Antipyretics (Phenytoin, Phenobarbital, Carbamazepine, etc.)
  • Patient who is taking androgens (Testosterone, etc.) or anti-androgens (5α-reductase inhibitors such as Finasteride, Dutasteride and anti- androgen hormones such as Flutamide and Bicalutamide)
  • Patient who is taking Trazodone
  • Patient who received other clinical trial medications (including placebo) within 4 weeks before the screening visit
  • History of hypersensitivity reactions to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug)
  • Patient who did not respond to PDE-5 inhibitors (Viagra®, Levitra®, Cialis®, Zydena®, Yaila®, Mvix® and each Generic drug)
  • Patient who has hypoactive sexual desire
  • If the examiner judges that it is not suitable for participation in this trial
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03142542
Other Study ID Numbers  ICMJE 2017-02-112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seong Soo Jeon, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Dong-A ST Co., Ltd.
Investigators  ICMJE
Principal Investigator: SeongSoo Jeon, PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP