Benign Prostatic HyperplasiaPhase 3NCT04947631
Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
A Phase 3 study testing DKF-313, Dutasteride and Tadalafil in people with Benign Prostatic Hyperplasia, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- DKF-313, Dutasteride and Tadalafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 667 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2021to 12 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- DKF-313, Dutasteride, Tadalafil, DKF-313 placebo, Dutasteride placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKF-313Drug
Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks
DutasterideDrug
Also called Avodart
Dutasteride 0.5 mg once daily for 48 weeks
TadalafilDrug
Also called Cialis
Tadalafil 5 mg once daily for 48 weeks
DKF-313 placeboDrug
Once daily for 48 weeks
Dutasteride placeboDrug
Once daily for 48 weeks
Tadalafil placeboDrug
Once daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| DKF-313 | Experimental | Dutasteride 0.5mg + Tadalafil 5mg Receives: Drug: DKF-313; Drug: Dutasteride placebo; Drug: Tadalafil placebo |
| Dutasteride | Active comparator | Dutasteride 0.5mg Receives: Drug: Dutasteride; Drug: DKF-313 placebo; Drug: Tadalafil placebo |
| Tadalafil | Active comparator | Tadalafil 5mg Receives: Drug: Tadalafil; Drug: DKF-313 placebo; Drug: Dutasteride placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48
Measured: Weeks 0 and 48
Secondary outcomes (8)
Change in Total International Prostate Symptom Score (IPSS) from baseline to Weeks 4, 12, 24 and 36
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 0, 4, 12, 24, 36 and 48
Change in Qmax from baseline to Weeks 24 and 48
Measured: Weeks 0, 24 and 48
Change in post void residual (PVR) volume from baseline to Weeks 24 and 48
Measured: Weeks 0, 24 and 48
Change in prostate volume (PV) from baseline to Week 48
Measured: Weeks 0 and 48
Change in prostate specific antigen (PSA) from baseline to Weeks 24 and 48
Measured: Weeks 0, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start27 Jul 2021
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choung-Soo Kim, M.D.,Ph.D, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947631
- Sponsor's protocol ID
- DKF-313-P3
- Status last verified
- Sep 2023
- First submitted
- 19 May 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04947631
- Acronym / sponsor ID
- DKF-313-P3
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DKF-313 | Experimental | Drug: DKF-313, Drug: Dutasteride placebo, Drug: Tadalafil placeboDutasteride 0.5mg + Tadalafil 5mg |
| Dutasteride | Active comparator | Drug: Dutasteride, Drug: DKF-313 placebo, Drug: Tadalafil placeboDutasteride 0.5mg |
| Tadalafil | Active comparator | Drug: Tadalafil, Drug: DKF-313 placebo, Drug: Dutasteride placeboTadalafil 5mg |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKF-313Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks | Drug | DKF-313 |
| DutasterideAlso: AvodartDutasteride 0.5 mg once daily for 48 weeks | Drug | Dutasteride |
| TadalafilAlso: CialisTadalafil 5 mg once daily for 48 weeks | Drug | Tadalafil |
| DKF-313 placeboOnce daily for 48 weeks | Drug | Dutasteride, Tadalafil |
| Dutasteride placeboOnce daily for 48 weeks | Drug | DKF-313, Tadalafil |
| Tadalafil placeboOnce daily for 48 weeks | Drug | DKF-313, Dutasteride |
Primary outcome
Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48
Time frame: Weeks 0 and 48
8 secondary outcomes
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
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
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
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
Change in Qmax from baseline to Weeks 24 and 48
Time frame: 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
Change in prostate volume (PV) from baseline to Week 48
Time frame: Weeks 0 and 48
Change in prostate specific antigen (PSA) from baseline to Weeks 24 and 48
Time frame: Weeks 0, 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choung-Soo Kim, M.D.,Ph.D principal investigator
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DKF-313, Dutasteride and Tadalafil in people with Benign Prostatic Hyperplasia, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48 (time frame: Weeks 0 and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.