Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation
NCT ID: NCT01798667
Last Updated: 2013-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
220 participants
INTERVENTIONAL
2013-01-31
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
PO administration
Placebo
Placebo of DA-8031, undistinguishable
DA-8031 dose 1
PO administration
DA-8031
DA-8031 dose 2
PO administration
DA-8031
DA-8031 dose 3
PO administration
DA-8031
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DA-8031
Placebo
Placebo of DA-8031, undistinguishable
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* PEDT score ≥ 11
Exclusion Criteria
* Serum Creatinine ≥ 2.5 mg/dl
* AST, ALT \> 3\*Upper limit of normal
* Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\>180/100mmHg)
* Subjects with chronic depression, psychiatric or schizophrenia,
* Subjects with alcohol, drug or substance abuse
20 Years
64 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sae Woong Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Du Geon Moon
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Nam-Cheol Park
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Jae-Seung Paick
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Tai-Young Ahn
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Sung Won Lee
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Ki Hak Moon
Role: PRINCIPAL_INVESTIGATOR
Yeongnam University Hospital
Kwangsung Park
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Jong Kwan Park
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Dae Yul Yang
Role: PRINCIPAL_INVESTIGATOR
Kangdong Sacred Heart Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Samsung Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sung Won Lee
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DA8031_PE_II
Identifier Type: -
Identifier Source: org_study_id