Overactive BladderPhase 2NCT03566134
A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder
A Phase 2 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
A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010 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
- 306 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2018to 27 Dec 2019
- Phase
- Phase 2
- 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 micturition 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
- Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
- Diagnosed with interstitial cystitis or bladder pain syndrome
- Clinically significant pelvic organ prolapse
- Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
- Medical history of malignant tumor in urinary system or pelvic organs
- Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010
- 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 mean number of micturitions per 24 hours
Change from baseline to Week 12 in mean number of micturitions per 24 hours
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start10 Jul 2018
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 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
- NCT03566134
- Sponsor's protocol ID
- DA8010_OAB_II
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT03566134
- Acronym / sponsor ID
- DA8010_OAB_II
- Conditions
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 21 Jun 2018 (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.
A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010
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 micturition 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 (6 listed)
- Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
- Diagnosed with interstitial cystitis or bladder pain syndrome
- Clinically significant pelvic organ prolapse
- Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
- Medical history of malignant tumor in urinary system or pelvic organs
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 mean number of micturitions per 24 hours
Time frame: 12 weeks
Change from baseline to Week 12 in mean number of micturitions per 24 hours
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 7 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 2 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 6 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 7 Feb 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mean number of micturitions per 24 hours (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 7 Feb 2020.