Clinical Trial: A Study of DA-8159 in Subjects With Erectile Dysfunction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase 2 Dose Ranging Trial To Assess The Safety and Efficacy of DA-8159 Tablets in Male Subjects With Erectile Dys

Brief Summary: The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects with erectile dysfunction (ED).

Detailed Summary:

This will be a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in 300 erectile dysfunction patients. Patients will complete a screening visit (V1) to determine eligibility for the study based on the International Index of Erectile Function (IIEF) erectile function (EF) domain scores, patient history and safety measures. Patients that meet the entrance criteria for this study will enter a 4 week, drug-free run-in period to establish a baseline for the erectile function domain score and to meet the criteria for participation in the study.

Patients successfully completing screen will be randomly assigned to one of four treatment groups at Visit 2 (V2): placebo or one of 3 active drug doses of DA-8159 tablets. Patients will be given medication for at-home use and will also be given diaries for recording information regarding sexual encounters, quality of erections and adverse events. At 4-week intervals for 3 months (V3, V4, V5), patients will return to the clinic to review and collect SEP diaries, safety data, 12-lead ECG and medication reconciliation. In addition, at each 4-week interval patients will complete an IIEF, and at Visit 5 will have blood drawn for safety evaluation.

The primary efficacy end points are: a) the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF, b) change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and c) change in response, relative to baseline, for SEP question 3. For DA-8159 tablets to be judged efficacious, the DA-8159 tablet groups must be shown superior to the placebo group on all three measures.


Sponsor: Dong-A PharmTech Co., Ltd.

Current Primary Outcome:

  • The primary efficacy end points are:
  • the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF;
  • change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and
  • change in response, relative to baseline, for SEP question 3.
  • Safety will be assessed by monitoring adverse events and changes in vital signs, clinical laboratory test results, 12-lead ECG, and physical examinations.


Original Primary Outcome:

  • The primary efficacy end points are:
  • a) the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF,
  • b) change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and
  • c) change in response, relative to baseline, for SEP question 3.
  • Safety will be assessed by monitoring adverse events and changes in vital signs, clinical laboratory test results, 12-lead ECG, and physical examinations.


Current Secondary Outcome:

  • The study has several secondary efficacy measurements including:
  • changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction domains of the IIEF,
  • changes from baseline in SEP questions 1, 4 and 5;
  • the global assessment questionnaire (GAQ), and
  • changes from baseline in patient self assessment questionnaire (PSAE) scores.


Original Secondary Outcome:

  • The study has several secondary efficacy measurements including:
  • a) changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction domains of the IIEF,
  • b) changes from baseline in SEP questions 1, 4 and 5,
  • c) the global assessment questionnaire (GAQ), and
  • d) changes from baseline in patient self assessment questionnaire (PSAE) scores.


Information By: Dong-A PharmTech Co., Ltd.

Dates:
Date Received: January 25, 2006
Date Started: May 2005
Date Completion: June 2006
Last Updated: February 27, 2007
Last Verified: February 2007