Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Overactive Bladder Clinical Trial

— POTTOR  

Official title:

Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488578
• Other study ID #: A6121186
• Status: Completed
• Start date: December 2006
• Est. completion date: March 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11157
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Tolterodine tartrate
Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).	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.	12 weeks
Primary	Number of Participants Which Was Evaluated as "Degree of Satisfaction".	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.	12 week
Primary	Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.	Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.	12 week
Primary	Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.	The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs	Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies	Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Gender	Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Complications	Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Age	Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.	12 week
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy	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.	12 week
Secondary	Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants	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.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder	Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency	Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)	Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day	Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.	12 week
Secondary	Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment	Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.	12 week

External Links

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