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Completed

NCT Number: NCT00454740

Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anchorage, Alaska, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with OAB who have been treated with tolterodine tartrate extended release for at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.
  • Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to Screening and is continued throughout the study.
  • At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.
  • Prior to treatment with tolterodine tartrate extended release, patients must have had OAB syndrome for 3 or more months.

Exclusion criteria

  • Previous treatment with darifenacin
  • Treatment with tolterodine tartrate extended release for less than 4 weeks prior to enrollment in the study.
  • Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
  • Evidence of a urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones.
  • Clinically significant outflow obstruction as determined by the Investigator
  • Uncontrolled narrow angle glaucoma, urinary or gastric retention.
  • All patients with severe renal or hepatic impairment will be excluded
  • Patients with chronic severe constipation or history of diagnosed gastrointestinal obstructive disease.

Treatment and study plan

Solifenacin succinate

Drug

Oral

Other names: VESIcare(R), YM905

Primary outcomes

  1. Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.

    Time frame: Weeks 1, 4, 8 and 12

Secondary outcomes

  1. To assess the improvement in urge incontinence, frequency,nocturia, and urgency

    Time frame: Weeks 1, 4, 8 and 12

  2. Number of patients satisfied with treatment

    Time frame: Weeks 1, 4, 8 and 12

  3. Assessment of efficacy

    Time frame: End of study

  4. Evaluation of the safety and tolerability

    Time frame: Baseline to end of study

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US

Acronym: VERSUS

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 2, 2007
Registry last updated
Sep 18, 2014

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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