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OpenTrials
Completed

NCT Number: NCT01578304

Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.

Completed

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Key information

Conditions

Overactive Bladder 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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients with overactive bladder aged 20 years or more
  • subject who had the continuos symptom for 3 months or more
  • subject prepare a symptom diary and was deemed eligible for the study by the investigator
  • 8 times or more of daily mean urination frequency
  • 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency

Exclusion criteria

  • subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
  • subjects with diseases prohibiting anti-cholinergics from administration
  • subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
  • subjects who received lower urinary tract surgery within 6 months
  • subjects with a catheter placed or intermittent catheterization
  • subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period
  • subjects who are within 1 month after other clinical study was completed
  • subjects having 100mL or more of residual urine
  • subjects who had acute urinary retention history
  • subjects who have been administered Prohibited concomitant medications

Treatment and study plan

imidafenacin

Drug

Tablet, 12 weeks twice daily

Fesoterodine

Drug

Tablet, 12 weeks once daily

Primary outcomes

  1. Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)

    Time frame: up to 12 weeks

Secondary outcomes

  1. Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)

    Time frame: up to 12 weeks

  2. Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)

    Time frame: up to 12 weeks

  3. Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)

    Time frame: up to 12 weeks

  4. Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0)

    Time frame: up to 12 weeks

  5. Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)

    Time frame: up to 12 weeks

  6. Adverse events

    Time frame: up to 24 weeks

  7. laboratory test

    Time frame: up to 12 weeks

  8. vital signs

    Time frame: up to 12 weeks

  9. residual urine

    Time frame: up to 12 weeks

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Collaborators

  • Kyorin Pharmaceutical Co.,Ltd

Registry information

Official study title

Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2012
Registry last updated
Apr 16, 2012

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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