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Trial record 1 of 1 for:    NCT01488578
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Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) (POTTOR)

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ClinicalTrials.gov Identifier: NCT01488578
Recruitment Status : Completed
First Posted : December 8, 2011
Results First Posted : June 14, 2012
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 27, 2011
First Posted Date December 8, 2011
Results First Submitted Date March 8, 2012
Results First Posted Date June 14, 2012
Last Update Posted Date June 14, 2012
Study Start Date December 2006
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2012)
  • Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). [ Time Frame: 12 weeks ]
    All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
  • Number of Participants Which Was Evaluated as "Degree of Satisfaction". [ Time Frame: 12 week ]
    Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.
  • Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. [ Time Frame: 12 week ]
    Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.
  • Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. [ Time Frame: 12 week ]
    The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.
Original Primary Outcome Measures
 (submitted: December 6, 2011)
  • Confirmation of the frequency of ADR. [ Time Frame: 12 weeks ]
  • Confirmation of the kind of main ADR. [ Time Frame: 12 week ]
  • Clinical overall effectiveness which was evaluated by investigators. [ Time Frame: 12 week ]
  • The degree of satisfaction of the patients. [ Time Frame: 12 week ]
Change History Complete list of historical versions of study NCT01488578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 11, 2012)
  • Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Gender [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Complications [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Age [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.
  • Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy [ Time Frame: 12 week ]
    Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.
  • Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants [ Time Frame: 12 week ]
    All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
  • Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day [ Time Frame: 12 week ]
    Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.
  • Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment [ Time Frame: 12 week ]
    Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.
Original Secondary Outcome Measures
 (submitted: December 6, 2011)
  • Confirmation of the kind of unknown ADR. [ Time Frame: 12 week ]
  • Confirmation of the factors which increase frequency of ADR. [ Time Frame: 12 week ]
  • Confirmation of the factors which decrease rate of the effectiveness [ Time Frame: 12 week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Official Title Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting
Brief Summary The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Detailed Description All the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).
Condition Overactive Bladder
Intervention Drug: Tolterodine tartrate
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.
Other Name: Detrusitol Capsule,Tolterodine tartrate.
Study Groups/Cohorts Tolterodine tartrate.
Subjects taking Tolterodine tartrate.
Intervention: Drug: Tolterodine tartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 6, 2011)
11157
Original Actual Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians.

Exclusion Criteria:

  • Subjects who have been prescribed Detrusitol Capsule before.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01488578
Other Study ID Numbers A6121186
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012