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

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ClinicalTrials.gov Identifier: NCT00170755
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 17, 2008
Sponsor:
Information provided by:
Novartis

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

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

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Darifenacin
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),


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

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 ClinicalTrials.gov identifier (NCT number): NCT00170755


Locations
United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936-108
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis East Hanover NJ

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00170755     History of Changes
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:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents