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This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction. (SPEED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705197
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

Tracking Information
First Submitted Date  ICMJE September 26, 2012
First Posted Date  ICMJE October 12, 2012
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Compare with the changes in IIEF(The International Index of Erectile Function)Erectile Function domain score between the study group and control group. [ Time Frame: 12 weeks ]
When changes in IIEF EF domain score of the study group (Avanafil-administered group) and control group (placebo-administered group) are compared to the baseline after 12 weeks post medication, it is to evaluate the superiority of the study group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Compare with the MSHQ, SEP Q2, SEP Q3 and GEAQ. [ Time Frame: 12 weeks ]
  1. When a dose is increased to 200mg because the effect is insufficient after 4 weeks of medication with Avanafil 100mg, it is to evaluate the effect of a dosage increase in IIEF EF domain, SEP Q2 and Q3.
  2. It is to evaluate changes in SEP (Q2, Q3, Q4 and Q5), other domains of IIEF (such as OF, SD, IS and OS domain), IIEF Q3, IIEF Q4, MSHQ, rate of subjects who score 26 and over in EF domain, GEAQ of the study group and control group compared to the baseline after 12 weeks post medication.
  3. Change in total score of IIEF EF domain, SEP Q2 and Q3; Comparison between the result from the 12th week and the result from the baseline and the 4th week.
[Glossary] MSHQ: Male Sexual Health Questionnaire SEP: Sexual Encounter Profile SEP Q2: Intercourse success rates on the Sexual Encounter Profile SEP Q3: Erectile success rates on the Sexual Encounter Profile GEAQ:Global Assessment Question
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 11, 2012)
We will be confirming the safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafil 100mg. [ Time Frame: 12weeks ]
  1. Comparative evaluate the variables of the study group and control group after medication: physical exam, vital sign(BP, pulse), ECG(Electrocardiogram, ECG=EKG), Laboratory tests, Adverse events
  2. We will check or confirm adverse events related to rates of adverse drug reactions and the disappearance time of adverse events.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction.
Official Title  ICMJE A Double-blind, Stratified Randomization, Placebo Controlled, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Avanafil in Subjects With Moderate to Severe Erectile Dysfunction in Korea.
Brief Summary The objective of this study is to evaluate the safety and efficacy of Avanafil in the treatment of erectile dysfunction with moderate to severe in subjects. And, this is to additionally confirm the efficacy and safety after initiating treatment with Avanafil 100mg and later increasing to 200mg, compared with continuing treatment with Avanafile 100mg, in subjects.
Detailed Description All subjects, who are judged to be suitable to the clinical trial after 4-week free run-in period was completed, should be administered with Avanafil 100mg(study group) or placebo 100mg(control group) for the first 4 weeks after randomization. When there are no moderate to severe adverse events at the 4 weeks evaluation after administration, and when it is decided by the researcher that the effect of Avanafil or placebo 100mg against erectile dysfunction is insufficient, a dosage increase to 200mg is executed. For subjects with a sufficient improvement effect on ED at 100mg, no dosage increase is allowed, and the previous 100mg administration should be maintained until the termination of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Drug: Avanafil 100 or 200mg
This study is designed as a double-blind, stratified randomized, placebo controlled, parallel group, multicenter, dose escalation study. For subjects with moderate to severe ED who have voluntarily signed the consent form, conduct screening and undertake the 4 weeks Free run-in period. For those who satisfy the study criteria during the review of subject's diaries composed during the free run-in period and the evaluation of inclusion/exclusion criteria at a future visit, drugs for each group are provided after randomized to Avanafil 100mg or placebo 100mg at a ratio of 2:1. At this time, subjects are random stratified to each group depending on their diabetes status.
Other Name: Zepeed 100mg or 200mg
Study Arms  ICMJE
  • Active Comparator: Avanfil 100 or 200mg
    All subjects, who are judged to be suitable to the clinical trial after 4-week free run-in period was completed, should be administered with Avanafil 100mg(study group) or placebo 100mg(control group) for the first 4 weeks after randomization. When there are no moderate to severe adverse events at the 4 weeks evaluation after administration, and when it is decided by the researcher that the effect of Avanafil or placebo 100mg against erectile dysfunction is insufficient, a dosage increase to 200mg is executed. For subjects with a sufficient improvement effect on ED at 100mg, no dosage increase is allowed, and the previous 100mg administration should be maintained until the termination of the study.
    Intervention: Drug: Avanafil 100 or 200mg
  • Placebo Comparator: Placebo 100mg or 200mg
    When there are no moderate to severe adverse events at the 4 weeks evaluation after administration, and when it is decided by the researcher that the effect of Avanafil or placebo 100mg against erectile dysfunction is insufficient, a dosage increase to 200mg is executed.
    Intervention: Drug: Avanafil 100 or 200mg
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2013)
195
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2012)
192
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male patients over 20 years old with a history of erectile dysfunction for at least 6 months prior to participation in the study
  2. Patients in a stable relationship with 1 female partner
  3. Patients whose sex partner is not in pregnancy or lactating, and is taking proper contraceptive
  4. Patients who have voluntarily decided to participate in this clinical trial, and signed the informed consent form
  5. Patients whose failure rate for sexual intercourse is more than 50% after attempts of sexual intercourse on more than 3 different days (once/day) at least during the 4-week Free run-in period
  6. Patients whose EF domain score is less than 18 points (moderate to severe erectile dysfunction) in the IIEF questionnaire after the 4-week Free run-in period

Exclusion Criteria:

  1. Patients who have a spinal injury or have had a radical prostatectomy
  2. Patients with anatomical malformations of the penis (example: angulation, fibrosis of corpus cavernosum, peyronies disease, etc.)
  3. Patients who had surgery in the pelvic cavity within 6 months prior to participation in the study
  4. Patients with neurogenic or endocrine (example: hyperprolactinemia, low testosterone, etc.) ED

    • Hyperprolactinemia: Serum prolactin ≥ 3 X ULN
    • Low testosterone: Total testosterone is less than the normal lower limit(testosterone is susceptible to daily changes, so enrollment is permitted after retesting before 11 am, only limited to once, when the number is 20% less than the normal lower limit.)
  5. Patients with a major refractory psychiatric disorder (including major depression or schizophrenia) or significant neurological abnormalities (neurovascular disease)
  6. Patients with alcohol addiction or persistent abuse of drugs of dependence
  7. Patients with hepatic dysfunction or renal dysfunction as per the following:

    • Hepatic dysfunction: AST, ALT ≥ 3 X ULN
    • Renal dysfunction: Serum creatinine > 2.0mg/dL
  8. Diabetic patients whose HbA1c exceeds 12%
  9. Patients with proliferative diabetic retinopathy
  10. Patients who have had a stroke, TIA(Transient ischemic attack), MI(Myocardial Infarction) or fatal arrhythmia, or severe heart failure, unstable angina or who underwent coronary artery bypass grafting (CABG) within the last 6 months prior to participation in the study
  11. Patients with hypotension (resting SBP/DBP in the sitting position is less than 90/50mmHg) or unregulated hypertension (resting SBP/DBP in the sitting position exceeds 170/100mmHg)
  12. Patients with hematopathy, which can be a predisposition to priapism (sickle-cell disease, multiple myeloma, leukemia)
  13. Patients with a known genetically degenerative retinopathy, including retinitis pigmentosa
  14. Patients who have had experience with avanafil, viagra, cialis, levitra, yaila, zydena, mvix or other ED treatment within 2 weeks from participation in the study
  15. Patients administered with the following medications:

    • Nitrate/Nitric oxide (NO) donors (example: nitroglycerin, isosorbide mononitrate, amyl nitrate/nitrite, sodium nitroprusside)
    • Androgens (example: testosterone), anti-androgen, trazodone
    • Anticoagulant (antiplatelet agents excluded)
    • Agents that significantly affect the CYP450 3A4 intermediary metabolism, such as erythromycin, intraconazol, ketoconazol, cimetidine, ritonavir, saquinavir, amprenavir, indinavir, and nelfinavir, etc.
  16. Patients who have had a history of hypersensitivity to other PDE-5 inhibitors or who have not responded to them
  17. Patients with primary hyposexuality
  18. Patients who have taken other investigational products within 4 weeks before the study
  19. For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate due to clinically significant findings according to the medical decision of the principal investigator or the study personnel
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years and older   (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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01705197
Other Study ID Numbers  ICMJE JW-AVA-302
임상제도과-2221 ( Other Identifier: KFDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JW Pharmaceutical
Study Sponsor  ICMJE JW Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim Se Woong, Doctor Catholic hospital in Korea
PRS Account JW Pharmaceutical
Verification Date March 2017

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