Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine Extended Release(ER)in Patients With Overactive Bladder.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00611026
First received: January 28, 2008
Last updated: January 28, 2011
Last verified: January 2011
  Purpose

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Condition Intervention Phase
Overactive Bladder
Drug: Tolterodine ER
Drug: Placebo
Drug: Fesoterodine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 12-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).


Secondary Outcome Measures:
  • Change From Baseline in Mean Voided Volume Per Micturition [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Mean voided volume in milliliters (mL) calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.

  • Change From Baseline in Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    The mean number of micturitions was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.

  • Percent Change From Baseline of Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline).

  • Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Mean number of nocturnal micturitions per 24 hours was calculated as the total number of all micturitions divided by the total number of diary days collected at that visit. Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.

  • Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (ie, 100%*(Week 1 or 4 or 12 - baseline)/baseline). Nocturnal micturitions are those recorded in the Bedtime section of the diary. Nocturnal (Bedtime) was defined as the time the participant went to bed until he/she arose to start the next day.

  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1 and Week 4 [ Time Frame: Baseline, Week 1, Week 4 ] [ Designated as safety issue: No ]
    UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Percent Change From Baseline of UUI Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]

    UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is

    1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.


  • Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Urgency Urinary episodes per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of ≥3 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Percent Change From Baseline in Mean Number of Urgency Urinary Episodes Per 24 Hours (Urinary Sensation Scale ≥3 in the Diary) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Percent change from baseline in mean number of Urgency Urinary episodes per 24 hours (Urinary Sensation Scale ≥3 in the diary). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Mean number of severe urgency episodes (USS rating ≥4 in diary ) per 24 hours calculated as the total number of micturitions with USS ≥4 divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Percent change calculated as change in severe urgency episodes (USS rating ≥4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Change From Baseline in Mean Urinary Sensation Scale (USS) Rating Per Micturition Per 24 Hours. [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the total number of micturitions per 24 hours with non-missing rating at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Change From Baseline in Frequency-Urgency Sum (FUS) Per 24 Hours (Synonymous With USS Sum in the Study Protocol) [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Frequency-Urgency Sum per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Diary Dry Rate: Percentage of Participants With no Urgency Urinary Incontinence (UUI) in the 3-day Bladder Diary [ Time Frame: Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
    Diary dry rate: percentage of participants with no urgency urinary incontinence episode reported in the 3 day diary at the respective time-point; based on USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

  • Change From Baseline in Patient Perception of Bladder Condition (PPBC) [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ] [ Designated as safety issue: No ]
    Number of participants in 4-point category: ≥2 points improvement (major improvement; negative change from baseline); 1 point improvement (minor improvement); no change; deterioration (positive change from baseline), based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.

  • Change From Baseline in Urgency Perception Scale (UPS). UPS Formerly Known as Patient Perception of Urgency Scale (PPUS) in the Protocol. [ Time Frame: Baseline, Week 1, Week, 4, Week 12 ] [ Designated as safety issue: No ]
    Number of participants in 3-point category: improvement [≥1-point improvement]; no change; deterioration [≥1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.

  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Negative change in Symptom Bother Score indicates improvement.

  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Health Related Quality of Life (HRQL) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

    HRQL domain and total raw score derived as sum of scores (6-point scale:

    1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score- Actual total raw score)/Raw score range] * 100. Higher transformed scores indicative of better HRQL. Positive change in HRQL Score indicates improvement.



Enrollment: 2417
Study Start Date: February 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Tolterodine ER
The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks.
Placebo Comparator: 2 Drug: Placebo
Placebo treatment will be once daily(QD) for 12 weeks.
Experimental: 3 Drug: Fesoterodine
The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
  • Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

  • Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
  • Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
  • Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611026

  Show 227 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00611026     History of Changes
Other Study ID Numbers: A0221046
Study First Received: January 28, 2008
Results First Received: October 12, 2010
Last Updated: January 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Treatment of overactive bladder

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

ClinicalTrials.gov processed this record on October 23, 2014