Overactive BladderPhase 3NCT05282069
A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
A Phase 3 study testing DA-8010 2.5mg, DA-8010 5mg and Solifenacin 5mg in people with Overactive Bladder, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- DA-8010 2.5mg, DA-8010 5mg and Solifenacin 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 607 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2022to 29 May 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main Inclusion at Screening (Visit 1):
- Men and women 19 years or older with OAB symptoms for ≥ 3 months.
- Subject who is willing and able to complete the voiding diary correctly.
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Who cannot join
- Main Exclusion at Screening (Visit 1):
- Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
- Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
- Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
- Clinically significant benign prostatic hyperplasia at the discretion of the investigator
- Had bladder or lower urinary tract surgery within 12 months from the screening visit
- Medical history of malignant tumor in urinary system or pelvic organs
- >150 mL of post-void residual volume in the screening test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.
- Conditions
- Overactive Bladder
- Being tested
- DA-8010 Placebo, DA-8010 2.5mg, DA-8010 5mg, Solifenacin 5mg, Solifenacin succinate placebo
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8010 PlaceboDrug
Participants receive placebo to match DA-8010 orally once a day.
DA-8010 2.5mgDrug
Participants receive DA-8010 2.5mg orally once a day.
DA-8010 5mgDrug
Participants receive DA-8010 5mg orally once a day.
Solifenacin 5mgDrug
Participants receive solifenacin 5 mg orally once a day.
Solifenacin succinate placeboDrug
Participants receive placebo to match solifenacin 5 mg orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | DA-8010 placebo + Solifenacin succinate placebo Receives: Drug: DA-8010 Placebo; Drug: Solifenacin succinate placebo |
| DA-8010 2.5mg | Experimental | DA-8010 2.5mg + Solifenacin succinate placebo Receives: Drug: DA-8010 2.5mg; Drug: Solifenacin succinate placebo |
| DA-8010 5mg | Experimental | DA-8010 5mg + Solifenacin succinate placebo Receives: Drug: DA-8010 5mg; Drug: Solifenacin succinate placebo |
| Solifenacin 5mg | Active comparator | DA-8010 placebo + Solifenacin succinate 5mg Receives: Drug: DA-8010 Placebo; Drug: Solifenacin 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Measured: 4 and 8 weeks
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start12 May 2022
- Primary completion1 Nov 2023
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282069
- Sponsor's protocol ID
- DA8010_OAB_III
- Status last verified
- Jun 2024
- First submitted
- 7 Mar 2022
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT05282069
- Acronym / sponsor ID
- DA8010_OAB_III
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 16 Mar 2022 (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 study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: DA-8010 Placebo, Drug: Solifenacin succinate placeboDA-8010 placebo + Solifenacin succinate placebo |
| DA-8010 2.5mg | Experimental | Drug: DA-8010 2.5mg, Drug: Solifenacin succinate placeboDA-8010 2.5mg + Solifenacin succinate placebo |
| DA-8010 5mg | Experimental | Drug: DA-8010 5mg, Drug: Solifenacin succinate placeboDA-8010 5mg + Solifenacin succinate placebo |
| Solifenacin 5mg | Active comparator | Drug: DA-8010 Placebo, Drug: Solifenacin 5mgDA-8010 placebo + Solifenacin succinate 5mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 19 years or older with OAB symptoms for ≥ 3 months.
- Subject who is willing and able to complete the voiding diary correctly.
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Key exclusion criteria (8 listed)
- Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
- Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
- Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
- Clinically significant benign prostatic hyperplasia at the discretion of the investigator
- Had bladder or lower urinary tract surgery within 12 months from the screening visit
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 |
|---|---|---|
| DA-8010 PlaceboParticipants receive placebo to match DA-8010 orally once a day. | Drug | Placebo, Solifenacin 5mg |
| DA-8010 2.5mgParticipants receive DA-8010 2.5mg orally once a day. | Drug | DA-8010 2.5mg |
| DA-8010 5mgParticipants receive DA-8010 5mg orally once a day. | Drug | DA-8010 5mg |
| Solifenacin 5mgParticipants receive solifenacin 5 mg orally once a day. | Drug | Solifenacin 5mg |
| Solifenacin succinate placeboParticipants receive placebo to match solifenacin 5 mg orally once a day. | Drug | DA-8010 2.5mg, DA-8010 5mg, Placebo |
Primary outcome
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
Time frame: 12 weeks
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
2 secondary outcomes
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Time frame: 4 and 8 weeks
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks
Time frame: 4, 8 and 12 weeks
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 26 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DA-8010 2.5mg, DA-8010 5mg and Solifenacin 5mg in people with Overactive Bladder, run by Dong-A ST 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 4 inclusion and 8 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 26 Jun 2024. 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. Some participants in this study may receive a placebo. 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 from baseline in the mean number of micturitions per 24 hours at 12 weeks (time frame: 12 weeks). 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 26 Jun 2024.