Clinical Trial to Evaluate the Efficacy and Safety of DA-... | NCT01798667

Studies
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

NCT01798667

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 15, 2013Estimated

Enrollment

220Estimated

Phase

Phase 2

Conditions

Premature Ejaculation

Interventions

DA-8031
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Apr 2013Actual

Completion Date

Sep 2013Estimated

First Submitted Date

Jan 27, 2013

First Submission Date that Met QC Criteria

Feb 22, 2013

First Posted Date

Feb 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2013

Last Update Posted Date

Aug 15, 2013Estimated

Description Module

Brief Summary

This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	PO administration	Drug: Placebo
DA-8031 dose 1	Experimental	PO administration	Drug: DA-8031
DA-8031 dose 2	Experimental	PO administration	Drug: DA-8031
DA-8031 dose 3	Experimental	PO administration	Drug: DA-8031

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-8031	Drug		DA-8031 dose 1 DA-8031 dose 2 DA-8031 dose 3
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
average IELT change		From 0 week(baseline) to 8 week(end of treatment)

Secondary Outcomes

Measure	Description	Time Frame
PEP, PGI	PEP(Primary ejaculation profile), PGI(Patient-reported global impression)	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients aged with premature ejaculation for more than 6 months.
PEDT score ≥ 11

Exclusion Criteria:

IIEF-EF domain ≤ 21
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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sung Won Lee	Contact			drswlee@skku.edu

Overall Officials

Name	Affiliation	Role
Sae Woong Kim	Seoul St. Mary's Hospital	Principal Investigator
Du Geon Moon	Korea University Guro Hospital	Principal Investigator
Nam-Cheol Park

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D061686	Premature Ejaculation

Ancestor Terms

ID	Term
D000097910	Ejaculatory Dysfunction
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C559089	DA 8031

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided