Urinary Bladder, OveractiveNCT00795509
Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).
An observational study of Urinary Bladder, Overactive, run by Pfizer.
Trial summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Tolterodine tartrate
- Type of treatment
- Pill or oral medicine
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).
Who may be able to join
- Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.
Who cannot join
- Patients not administered Detrusitol® Capsule.
About this study
Official title: Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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.
Read the detailed description
All the patients 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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Tolterodine tartrate
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine tartrateDrug
Also called Detrusitol® Capsule.
Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability."
| Study group | Role | What they receive |
|---|---|---|
| Tolterodine tartrate. | Patients taking Tolterodine tartrate. Receives: Drug: Tolterodine tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted 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. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Measured: 52 weeks
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startAug 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795509
- Sponsor's protocol ID
- A6121187
- Status last verified
- Jun 2012
- First submitted
- 19 Nov 2008
- Last updated
- 9 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).
- ClinicalTrials.gov ID
- NCT00795509
- Acronym / sponsor ID
- A6121187
- Conditions
- Urinary Bladder, Overactive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Posted 9 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (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 patients 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolterodine tartrate. | – | Drug: Tolterodine tartratePatients taking Tolterodine tartrate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A6121187 prescribes the Tolterodine tartrate (Detrusitol® Capsule).
Key inclusion criteria (1 listed)
- Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance.
Key exclusion criteria (1 listed)
- Patients not administered Detrusitol® Capsule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolterodine tartrateAlso: Detrusitol® Capsule.Detrusitol® Capsule 2mg and 4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability." | Drug | Tolterodine tartrate. |
Primary outcome
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).
Time frame: 52 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. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).
Time frame: 52 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012.