Overactive Bladder SyndromePhase 3NCT00170755
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
A Phase 3 study testing Darifenacin in people with Overactive Bladder Syndrome, run by Novartis at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Darifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jan 2005
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
- Patients capable of independent toileting and able of independently completing the patient diary.
Who cannot join
- Patients in whom the use of anticholinergic drugs was contraindicated
- Evidence of severe liver disease
- Patients with other clinically significant urinary or gynecological conditions
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Darifenacin
- Keywords
- Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
- 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.
DarifenacinDrug
Also called Enablex
Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Darifenacin Receives: Drug: Darifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.
Secondary outcomes (2)
Long term efficacy on the symptoms of overactive bladder
King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, East Hanover NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170755
- Sponsor's protocol ID
- CDAR328A2301
- Status last verified
- Jan 2008
- First submitted
- 9 Sep 2005
- Last updated
- 17 Jan 2008
- Results posted
- No
Publications
Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27(6):540-7. doi: 10.1002/nau.20620.
PubMed 18663723
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00170755
- Acronym / sponsor ID
- CDAR328A2301
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Jan 2005 (actual)
- First posted
- 15 Sep 2005 (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.
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DarifenacinDarifenacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
- Patients capable of independent toileting and able of independently completing the patient diary.
Key exclusion criteria (4 listed)
- Patients in whom the use of anticholinergic drugs was contraindicated
- Evidence of severe liver disease
- Patients with other clinically significant urinary or gynecological conditions
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| DarifenacinAlso: EnablexDarifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily | Drug | 1 |
Primary outcome
Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.
2 secondary outcomes
Long term efficacy on the symptoms of overactive bladder
King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),
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 17 Jan 2008.
- Derived from this study: PubMed 18663723Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27(6):540-7. doi: 10.1002/nau.20620.
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Active, not recruitingPhase 2/3
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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.
Novartis study chair
East Hanover NJ
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 Darifenacin in people with Overactive Bladder Syndrome, run by Novartis at 1 site in United States.
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 2 inclusion and 4 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 17 Jan 2008. 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 United States. 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?
Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00170755, which also lists 1 linked publication.
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 17 Jan 2008.