Skip to main content
OpenTrials
Completed

NCT Number: NCT00170755

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overactive Bladder Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis

East Hanover, New Jersey, 07936-108, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darifenacin

Drug

Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily

Other names: Enablex

Primary outcomes

  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 outcomes

  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),

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.