Overactive BladderPhase 4NCT01578304
Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder
A Phase 4 study testing Imidafenacin and Fesoterodine in people with Overactive Bladder, run by LG Life Sciences at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Imidafenacin and Fesoterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Oct 2011
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with overactive bladder aged 20 years or more
- subject who had the continuos symptom for 3 months or more
- subject prepare a symptom diary and was deemed eligible for the study by the investigator
- 8 times or more of daily mean urination frequency
- 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency
Who cannot join
- subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
- subjects with diseases prohibiting anti-cholinergics from administration
- subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
- subjects who received lower urinary tract surgery within 6 months
- subjects with a catheter placed or intermittent catheterization
- subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period
Show all 10Show fewer
- subjects who are within 1 month after other clinical study was completed
- subjects having 100mL or more of residual urine
- subjects who had acute urinary retention history
- subjects who have been administered Prohibited concomitant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder
To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- Imidafenacin, Fesoterodine
- Keywords
- Overactive bladder
- 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.
ImidafenacinDrug
Tablet, 12 weeks twice daily
FesoterodineDrug
Tablet, 12 weeks once daily
| Study group | Role | What they receive |
|---|---|---|
| Imidafenacin | Experimental | Not described Receives: Drug: Imidafenacin |
| Fesoterodine | Active comparator | Not described Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)
Measured: up to 12 weeks
Secondary outcomes (9)
Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Measured: up to 12 weeks
Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Measured: up to 12 weeks
Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Measured: up to 12 weeks
Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0)
Measured: up to 12 weeks
Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Measured: up to 12 weeks
Adverse events
Measured: up to 24 weeks
laboratory test
Measured: up to 12 weeks
vital signs
Measured: up to 12 weeks
residual urine
Measured: up to 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 Apr 2012 (estimated)
- Study startDec 2010
- Primary completionOct 2011
- Study completionOct 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyorin Pharmaceutical Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- KYU-SUNG LEE, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578304
- Sponsor's protocol ID
- LG-IFCL002
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT01578304
- Acronym / sponsor ID
- LG-IFCL002
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Kyorin Pharmaceutical Co.,Ltd
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Apr 2012 (estimated)
- 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.
To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imidafenacin | Experimental | Drug: Imidafenacin |
| Fesoterodine | Active comparator | Drug: Fesoterodine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients with overactive bladder aged 20 years or more
- subject who had the continuos symptom for 3 months or more
- subject prepare a symptom diary and was deemed eligible for the study by the investigator
- 8 times or more of daily mean urination frequency
- 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency
Key exclusion criteria (10 listed)
- subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
- subjects with diseases prohibiting anti-cholinergics from administration
- subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
- subjects who received lower urinary tract surgery within 6 months
- subjects with a catheter placed or intermittent catheterization
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 |
|---|---|---|
| ImidafenacinTablet, 12 weeks twice daily | Drug | Imidafenacin |
| FesoterodineTablet, 12 weeks once daily | Drug | Fesoterodine |
Primary outcome
Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)
Time frame: up to 12 weeks
9 secondary outcomes
Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Time frame: up to 12 weeks
Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Time frame: up to 12 weeks
Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Time frame: up to 12 weeks
Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0)
Time frame: up to 12 weeks
Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)
Time frame: up to 12 weeks
Adverse events
Time frame: up to 24 weeks
laboratory test
Time frame: up to 12 weeks
vital signs
Time frame: up to 12 weeks
residual urine
Time frame: up to 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 16 Apr 2012.
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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.
KYU-SUNG LEE, M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imidafenacin and Fesoterodine in people with Overactive Bladder, run by LG Life Sciences 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 5 inclusion and 10 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 16 Apr 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0) (time frame: up to 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 16 Apr 2012.