Trial Outcomes & Findings for Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) (NCT NCT01488578)

NCT ID: NCT01488578

Last Updated: 2021-01-28

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.

• Recruitment status: COMPLETED
• Target enrollment: 11157 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2021-01-28

Participant Flow

Participant milestones

Measure	Tolterodine Tartrate Participants taking Tolterodine tartrate.
Overall Study STARTED	11157
Overall Study COMPLETED	9321
Overall Study NOT COMPLETED	1836

Reasons for withdrawal

Measure	Tolterodine Tartrate Participants taking Tolterodine tartrate.
Overall Study Protocol Violation	1836

Baseline Characteristics

Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Baseline characteristics by cohort

Measure	Tolterodine Tartrate n=9321 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.
Age, Customized <65 years	2848 participants n=5 Participants
Age, Customized >=65 years	6473 participants n=5 Participants
Sex: Female, Male Female	5263 Participants n=5 Participants
Sex: Female, Male Male	4058 Participants n=5 Participants
Target disease severity Mild	3530 participants n=5 Participants
Target disease severity Moderate	5185 participants n=5 Participants
Target disease severity Severe	606 participants n=5 Participants
Complications Present	5837 participants n=5 Participants
Complications Absent	3484 participants n=5 Participants
Concomitant drug Present	5057 participants n=5 Participants
Concomitant drug Absent	4246 participants n=5 Participants
Starting dose 2 mg	1813 participants n=5 Participants
Starting dose 4 mg	7506 participants n=5 Participants
Starting dose 8 mg	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

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.

Outcome measures

Measure	Tolterodine Tartrate n=9321 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).	984 participants	—	—	—

PRIMARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

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.

Outcome measures

Measure	Tolterodine Tartrate n=7780 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Number of Participants Which Was Evaluated as "Degree of Satisfaction". Satisfied	5609 participants	—	—	—
Number of Participants Which Was Evaluated as "Degree of Satisfaction". Dissatisfied	1033 participants	—	—	—
Number of Participants Which Was Evaluated as "Degree of Satisfaction". Neither of the above	963 participants	—	—	—
Number of Participants Which Was Evaluated as "Degree of Satisfaction". Unknown	175 participants	—	—	—

PRIMARY outcome

Timeframe: 12 week

Population: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated. Number of participants evaluable for which was evaluated "effect".

Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.

Outcome measures

Measure	Tolterodine Tartrate n=7780 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. Effective	6536 participants	—	—	—
Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. Not effective	1244 participants	—	—	—

PRIMARY outcome

Timeframe: 12 week

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

The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.

Outcome measures

Measure	Tolterodine Tartrate n=9321 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. Thirst	344 events	—	—	—
Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. Constipation	194 events	—	—	—
Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. Dysuria	166 events	—	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=4214 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=3566 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs	3483 participants	3053 participants	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=360 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=7420 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies	317 participants	6219 participants	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=3394 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=4386 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Gender	2745 participants	3791 participants	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=4806 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=2974 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Complications	3960 participants	2576 participants	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=2379 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=5401 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Age	2060 participants	4476 participants	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.

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.

Outcome measures

Measure	Tolterodine Tartrate n=2203 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=1855 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy	319 participants	130 participants	—	—

SECONDARY outcome

Timeframe: 12 week

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

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.

Outcome measures

Measure	Tolterodine Tartrate n=9321 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Abdominal discomfort	18 events	—	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Pollakiuria	11 events	—	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Cystitis	10 events	—	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Abdominal distension	10 events	—	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Pruritus	6 events	—	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Stomatitis	5 events	—	—	—
Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants Malaise	5 events	—	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=2896 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=4378 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe n=506 Participants Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder	2426 participants	3709 participants	401 participants	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=6521 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=1043 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency	5529 participants	829 participants	—	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=442 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=1021 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe n=1600 Participants Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations n=4223 Participants Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)	370 participants	882 participants	1380 participants	3523 participants

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=1913 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=836 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe n=322 Participants Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day	1670 participants	710 participants	254 participants	—

SECONDARY outcome

Timeframe: 12 week

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.

Outcome measures

Measure	Tolterodine Tartrate n=943 Participants Participants taking Tolterodine tartrate according to Japanese Package Insert.	Without Concomitant Drugs n=6736 Participants Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.	Severe Participants with severe OAB who took tolterodine according to Japanese Package Insert.	>= 3 Urinations Participants with \>= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment	698 participants	5753 participants	—	—

Adverse Events

Tolterodine Tartrate

Serious events: 12 serious events

Other events: 703 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tolterodine Tartrate n=9321 participants at risk Participants taking Tolterodine tartrate according to Japanese Package Insert.
Renal and urinary disorders Urinary retention	0.04% 4/9321 • 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.
Gastrointestinal disorders Intestinal obstruction	0.02% 2/9321 • Number of events 2 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.
Infections and infestations Pyelonephritis acute	0.01% 1/9321 • 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.
Nervous system disorders Dementia	0.01% 1/9321 • 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.
Nervous system disorders Dizziness	0.01% 1/9321 • 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.
Ear and labyrinth disorders Vertigo	0.01% 1/9321 • 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.
Skin and subcutaneous tissue disorders Rash	0.01% 1/9321 • 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.
Renal and urinary disorders Dysuria	0.01% 1/9321 • 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

Measure	Tolterodine Tartrate n=9321 participants at risk Participants taking Tolterodine tartrate according to Japanese Package Insert.
General disorders Thirst	3.7% 344/9321 • Number of events 344 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	2.1% 194/9321 • Number of events 194 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 Dysuria	1.8% 165/9321 • Number of events 165 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: ClinicalTrials.gov_Inquiries@pfizer.com

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