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A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170755
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 17, 2008
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Brief Summary:
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: Darifenacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 718 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Study Start Date : April 2002
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Darifenacin
Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
Other Name: Enablex

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Long term efficacy on the symptoms of overactive bladder
  2. 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),

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170755

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United States, New Jersey
East Hanover, New Jersey, United States, 07936-108
Sponsors and Collaborators
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Study Chair: Novartis East Hanover NJ
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: External Affairs, Novartis Identifier: NCT00170755    
Other Study ID Numbers: CDAR328A2301
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008
Keywords provided by Novartis:
Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents