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Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) (POTTOR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01488578
First received: April 27, 2011
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Overactive Bladder
Drug: Tolterodine tartrate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.


Secondary Outcome Measures:
  • Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.


Enrollment: 11157
Study Start Date: December 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tolterodine tartrate.
Subjects taking Tolterodine tartrate.
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).

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.
  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: NCT01488578

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01488578     History of Changes
Other Study ID Numbers: A6121186
Study First Received: April 27, 2011
Results First Received: March 8, 2012
Last Updated: May 11, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Overactive Bladder
Japanese
Tolterodine
Detrusitol
Detrol
Postmarketing commitment plan.

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Phenylpropanolamine
Tolterodine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Urological Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014