Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) (POTTOR)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01488578
First received: April 27, 2011
Last updated: May 11, 2012
Last verified: May 2012
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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
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 Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Tolterodine Phenylpropanolamine Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013