Trial Outcomes & Findings for Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan). (NCT NCT00795509)

Last Updated: 2012-07-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

374 participants

Primary outcome timeframe

52 weeks

Results posted on

2012-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Tolterodine Tartrate. Participants taking Tolterodine tartrate.
Overall Study STARTED	374
Overall Study COMPLETED	343
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Tolterodine Tartrate. Participants taking Tolterodine tartrate.
Overall Study Protocol Violation	31

Baseline Characteristics

Special Investigation For Long Term Use Of Tolterodine (Regulatory Post Marketing Commitment Plan).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tolterodine Tartrate. n=343 Participants Participants taking Tolterodine tartrate.
Age, Customized <65 years	98 participants n=5 Participants
Age, Customized >= 65 years	245 participants n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants
Target disease severity Mild	135 participants n=5 Participants
Target disease severity Moderate	194 participants n=5 Participants
Target disease severity Severe	14 participants n=5 Participants
Complications Present	266 participants n=5 Participants
Complications Absent	77 participants n=5 Participants
Concomitant drug Present	256 participants n=5 Participants
Concomitant drug Absent	87 participants n=5 Participants
Treatment Period Less than 12 weeks	1 participants n=5 Participants
Treatment Period 12 to 24 weeks	44 participants n=5 Participants
Treatment Period 24 to 52 weeks	88 participants n=5 Participants
Treatment Period 52 to 76 weeks	172 participants n=5 Participants
Treatment Period 76 to 104 weeks	31 participants n=5 Participants
Treatment Period Over 104 weeks	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.

Outcome measures

Outcome measures
Measure	Tolterodine Tartrate. n=343 Participants Participants taking Tolterodine tartrate.
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). Glaucoma	1 participants
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). Death	1 participants
Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs). Abdominal discomfort	1 participants

PRIMARY outcome

Timeframe: 52 weeks

Population: Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.

Outcome measures

Outcome measures
Measure	Tolterodine Tartrate. n=343 Participants Participants taking Tolterodine tartrate.
Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).	25 participants

Adverse Events

Tolterodine Tartrate.

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tolterodine Tartrate. n=343 participants at risk Participants taking Tolterodine tartrate.
General disorders Death	0.29% 1/343 • Number of events 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure	Tolterodine Tartrate. n=343 participants at risk Participants taking Tolterodine tartrate.
Renal and urinary disorders Dysuria	2.3% 8/343 • Number of events 8 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	1.7% 6/343 • Number of events 6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Thirst	1.7% 6/343 • Number of events 6 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	1.2% 4/343 • Number of events 4 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Residual urine volume increased	0.87% 3/343 • Number of events 3 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizzines	0.29% 1/343 • Number of events 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Glaucoma	0.29% 1/343 • Number of events 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	0.29% 1/343 • Number of events 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER