Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

September 18, 2023 updated by: Dongkook Pharmaceutical Co., Ltd.

A Multi-center, Randomized, Double-blinded, Double-dummy, Parallel Group, 48-week, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

This is a multi-center, randomized, double-blinded, double-dummy, parallel group, 48-week study to evaluated the efficacy and safety of DKF-313 (dutasteride and tadalafil) in patients with benign prostatic hyperplasia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is conducted to access whether DKF-313 once daily for 48 weeks is superior to dutasteride 0.5 mg once daily and tadalafil 5 mg once daily each in improving BPH-LUTS as measured by changes in IPSS total scores.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
667

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male aged 45 to 80 years
  • BPH diagnosis
  • Voluntarily signed the informed consent form
  • Willing to participate in the study
  • Total IPSS 13 or greater at baseline
  • Prostate volume 30 cc or greater by TRUS at baseline
  • Qmax 4 to 15 mL/s and minimum voided volume 125 mL or greater at baseline

Exclusion Criteria:

  • Serum PSA 4 ng/mL or greater with a positive biopsy result
  • Malignant urogenital tumors including prostate cancer, bladder cancer, etc.
  • Previous prostatic surgery including TURP, balloon dilatation, thermotherapy and stent replacement or other invasive procedures to treat prostate
  • Prostate biopsy within 4 weeks of screening
  • Use of alpha-blockers, alpha-agonists, phosphodiesterase type 5 (PDE5) inhibitors, antidiuretics, anticholinergics, cholinergics, antispasmodics, nitrates or herbal preparations affecting prostate within 4 weeks of screening, or 5-alpha reductase inhibitors (5-ARIs) within 24 weeks of screening
  • Acute urinary retention within 12 weeks of screening
  • Any causes other than BPH resulting in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infections)
  • Bladder postvoid residual 200 mL or greater
  • Anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or conditions that might predispose to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
  • Cardiovascular diseases such as myocardial infarction within 12 weeks of screening, unstable angina or angina during sexual intercourse, heart failure (NYHA Class 2 or higher) within 24 weeks of screening, uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled hypertension (>170/100 mmHg), or stroke within 24 weeks of screening
  • Left ventricular outflow obstruction (e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis)
  • Inherited disorders including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Inherited retinal degeneration including retinitis pigmentosa
  • Vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION)
  • Hypersensitivity to ingredients of investigational products
  • Alcohol or drug abuse or treating psychiatric disorders
  • Severe hepatic impairment (ALT or AST > 3xULN)
  • Renal impairment with severe heart failure (serum creatinine > 2xULN)
  • Uncontrolled diabetes (HbA1c 9% or greater)
  • Other investigational products or procedures within 12 weeks of screening
  • Plans to have a child or unwilling to comply with using medically accepted contraception methods (such as surgical sterilization and condom) during the treatment period
  • Not eligible due to other reasons at the investigator's discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DKF-313
Dutasteride 0.5mg + Tadalafil 5mg
Drug: DKF-313
Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks
Drug: Dutasteride placebo
Once daily for 48 weeks
Drug: Tadalafil placebo
Once daily for 48 weeks
Active Comparator: Dutasteride
Dutasteride 0.5mg
Drug: Tadalafil placebo
Once daily for 48 weeks
Drug: Dutasteride
Dutasteride 0.5 mg once daily for 48 weeks
Other Names:
  • Avodart
Drug: DKF-313 placebo
Once daily for 48 weeks
Active Comparator: Tadalafil
Tadalafil 5mg
Drug: Dutasteride placebo
Once daily for 48 weeks
Drug: DKF-313 placebo
Once daily for 48 weeks
Drug: Tadalafil
Tadalafil 5 mg once daily for 48 weeks
Other Names:
  • Cialis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48
Time Frame: Weeks 0 and 48
Weeks 0 and 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Total International Prostate Symptom Score (IPSS) from baseline to Weeks 4, 12, 24 and 36
Time Frame: Weeks 0, 4, 12, 24 and 36
Weeks 0, 4, 12, 24 and 36
Change in Total International Prostate Symptom Score (IPSS) voiding (obstructive) subscores from baseline to Weeks 4, 12, 24, 36 and 48
Time Frame: Weeks 0, 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Total International Prostate Symptom Score (IPSS) storage (irritative) subscores from baseline to Weeks 4, 12, 24, 36 and 48
Time Frame: Weeks 0, 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Total International Prostate Symptom Score (IPSS) Quality of Life (QoL) index from baseline to Weeks 4, 12, 24, 36 and 48
Time Frame: Weeks 0, 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Qmax from baseline to Weeks 24 and 48
Time Frame: Weeks 0, 24 and 48
Weeks 0, 24 and 48
Change in post void residual (PVR) volume from baseline to Weeks 24 and 48
Time Frame: Weeks 0, 24 and 48
Weeks 0, 24 and 48
Change in prostate volume (PV) from baseline to Week 48
Time Frame: Weeks 0 and 48
Weeks 0 and 48
Change in prostate specific antigen (PSA) from baseline to Weeks 24 and 48
Time Frame: Weeks 0, 24 and 48
Weeks 0, 24 and 48

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in International Index of Erectile Function (IIEF) - Erectile Function (EF) domain scores from baseline to Weeks 4, 12, 24, 36 and 48
Time Frame: Weeks 0, 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48
Change in Sexual Encounter Profile (SEP) Q2 and Q3 from baseline to Weeks 4, 12, 24, 36 and 48
Time Frame: Weeks 0, 4, 12, 24, 36 and 48
Weeks 0, 4, 12, 24, 36 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dongkook Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Choung-Soo Kim, M.D.,Ph.D, Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DKF-313-P3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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