- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170755
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
January 15, 2008 updated by: Novartis
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
Study Overview
Study Type
Interventional
Enrollment (Actual)
718
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936-108
- Novartis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Darifenacin
|
Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Long term efficacy on the symptoms of overactive bladder
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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),
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis, East Hanover NJ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
January 17, 2008
Last Update Submitted That Met QC Criteria
January 15, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Darifenacin
Other Study ID Numbers
- CDAR328A2301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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PfizerCompleted
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Clinical Trials on Darifenacin
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NovartisProcter and GambleCompleted
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BayerCompleted
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BayerTerminatedMultiple Sclerosis | Overactive DetrusorGermany
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BayerCompletedOveractive BladderSouth Africa
-
McGill UniversityUniversité de MontréalNot yet recruitingAmyotrophic Lateral SclerosisCanada
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US Department of Veterans AffairsCompletedOveractive Bladder | Parkinson's DiseaseUnited States
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Toronto Rehabilitation InstituteOntario Neurotrauma FoundationCompletedSpinal Cord Injury | Neurogenic Detrusor OveractivityCanada
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NovartisProcter and GambleCompletedOveractive BladderUnited States