Overactive BladderPhase 2NCT01458197
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
A Phase 2 study testing Tarafenacin 0.2 mg and Tarafenacin 0.4 mg in people with Overactive Bladder, run by Kwang Dong Pharmaceutical co., ltd. at 1 site in South Korea.
Trial summary
1. Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy. 2. Secondary Objectives: To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. . Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tarafenacin 0.2 mg and Tarafenacin 0.4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Nov 2012
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
< Inclusion Criteria>
- Patient of either sex aged 20 to 80 years (both inclusive);
- Patients suffering from Overactive Bladder. based on cardinal symptoms (urgency, nocturia, frequency with or without urge incontinence) for at least 6 months prior to inclusion;
- Patients who document the following symptoms in a 3-day diary card during the 14 day placebo run-in period
- An average of ≥8 micturitions/24 hours;
- Greater than or equal to three incontinence episodes
- A total of ≥3 urgency episodes.
<Exclusion Criteria>
- Patients with Clinically significant bladder outlet obstruction
- Patients with predominant stress incontinence (>2 episode/week)
- Patients with significant urogenital disease such as recurrent urinary tract infection (more than 2/6 months), bladder calculi, interstitial cystitis, urothelial tumours, hysterectomy or prostatectomy in the previous six months;
- Females diagnosed with bladder cancer
- Males diagnosed with bladder cancer
- Patients with obstructive disease of the gastrointestinal tract, intestinal inflammatory disease, severe ulcerative colitis, inflammatory bowel disease, toxic megacolon, intestinal atony or paralytic ileum
- Patients with acute Noehyeolgwangye disease, significant Cardiovascular Disease (arrhythmias, unstable angina pectoris, myocardial infarct, or are using a pacemaker), significant Orthostatic hypotension in the previous six months
- Patients diagnosed with closed angle glaucoma or shallowness of the anterior chamber
- Patients with any contraindication to antimuscarinic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Placebo-controlled, Randomized, Double-blind, Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo Administered as Oral Daily Dose for Three Months in Patients Suffering From Overactive Bladder.
- Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy.
- Secondary Objectives:
- To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
- To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
- Conditions
- Overactive Bladder
- Being tested
- Tarafenacin 0.2 mg, Placebo, Tarafenacin 0.4 mg
- Keywords
- Overactive Bladder, Tarafenacin
- 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.
Tarafenacin 0.2 mgDrug
Capsule, qd, 12 weeks
PlaceboDrug
Capsule, qd, 12 weeks
Tarafenacin 0.4 mgDrug
Capsule, qd, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tarafenacin 0.2 mg | Experimental | Group 1 Receives: Drug: Tarafenacin 0.2 mg |
| Tarafenacin 0.4 mg | Experimental | Group 2 Receives: Drug: Tarafenacin 0.4 mg |
| Placebo | Placebo comparator | Group 3 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period
Measured: 12 weeks
Secondary outcomes (5)
Mean change from baseline to 12weeks in Number of urgency episodes
Measured: 12 weeks
Mean change from baseline to 12weeks in Number of incontinence episodes
Measured: 12 weeks
Mean change from baseline to 12weeks in Number of nocturia episodes
Measured: 12weeks
Mean change from baseline to 12weeks in Volume of urine passed per void
Measured: 12weeks
Mean change from baseline to 12weeks in score of King's Health Questionnaire
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionNov 2012
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Soo Choo, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458197
- Sponsor's protocol ID
- TFN-KD01
- Status last verified
- Mar 2014
- First submitted
- 19 Oct 2011
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Placebo-controlled, Randomized, Double-blind, Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo Administered as Oral Daily Dose for Three Months in Patients Suffering From Overactive Bladder.
- ClinicalTrials.gov ID
- NCT01458197
- Acronym / sponsor ID
- TFN-KD01
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, Tarafenacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Oct 2011 (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.
- Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy.
- Secondary Objectives:
- To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
- To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tarafenacin 0.2 mg | Experimental | Drug: Tarafenacin 0.2 mgGroup 1 |
| Tarafenacin 0.4 mg | Experimental | Drug: Tarafenacin 0.4 mgGroup 2 |
| Placebo | Placebo comparator | Drug: PlaceboGroup 3 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tarafenacin 0.2 mgCapsule, qd, 12 weeks | Drug | Tarafenacin 0.2 mg |
| PlaceboCapsule, qd, 12 weeks | Drug | Placebo |
| Tarafenacin 0.4 mgCapsule, qd, 12 weeks | Drug | Tarafenacin 0.4 mg |
Primary outcome
the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period
Time frame: 12 weeks
5 secondary outcomes
Mean change from baseline to 12weeks in Number of urgency episodes
Time frame: 12 weeks
Mean change from baseline to 12weeks in Number of incontinence episodes
Time frame: 12 weeks
Mean change from baseline to 12weeks in Number of nocturia episodes
Time frame: 12weeks
Mean change from baseline to 12weeks in Volume of urine passed per void
Time frame: 12weeks
Mean change from baseline to 12weeks in score of King's Health Questionnaire
Time frame: 12weeks
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 12 Mar 2014.
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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.
Myung-Soo Choo, Professor principal investigator
Asan 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 2 study testing Tarafenacin 0.2 mg and Tarafenacin 0.4 mg in people with Overactive Bladder, run by Kwang Dong 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?
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 12 Mar 2014. 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?
the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period (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 12 Mar 2014.