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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170755
First received: September 9, 2005
Last updated: January 15, 2008
Last verified: January 2008
History of Changes
  Purpose

This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.


Condition Intervention Phase
Overactive Bladder Syndrome
 Drug: Darifenacin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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),

Enrollment: 718
Study Start Date: April 2002
Study Completion Date: January 2005
Arms Assigned Interventions
Experimental: 1
Darifenacin
 Drug: Darifenacin
Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
Other Name: Enablex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Novartis

Additional 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
Study First Received: September 9, 2005
Last Updated: January 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Darifenacin
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013