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OpenTrials
Completed

NCT Number: NCT00171145

A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.

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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

  • Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
  • 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 15 mg tablets once daily

Other names: Enablex

Placebo

Drug

Placebo tablets once daily

Primary outcomes

  1. Change from baseline in warning time at week 12.

Secondary outcomes

  1. Change in warning time at weeks 2 & 6.

  2. Change in frequency of urge incontinence episodes.

  3. Change in frequency of micturitions.

  4. Change in mean volume per void.

  5. Change in frequency of urgency.

  6. Safety and tolerability.

  7. Quality of life.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Study completion
2004
First posted
Sep 15, 2005
Registry last updated
Jan 23, 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.

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