Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tolterodine · 4 trials · 3 indications
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | 4 mg tolterodine extended release capsules, administered with water and under fasting condition. |
| B | EXPERIMENTAL | 4 mg microspheres in powder blend release rate 2 (MPB-RR2), administered without water and under fasting condition. |
| C | EXPERIMENTAL | 4 mg microspheres in powder blend release rate 1 (MPB-RR1), administered without water and under fasting condition. |
| D | EXPERIMENTAL | 4 mg MPB-RR1, administered without water and under fed condition. |
| E | EXPERIMENTAL | 4 mg MPB-RR1, administered with water and under fasting condition. |
| Tolterodine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| tolterodine extended release capsule | DRUG | - |
| Tolterodine ER | DRUG | The tolterodine treatment will be 4 mg once daily(QD) for 12 weeks. |
| Placebo | DRUG | Placebo treatment will be once daily(QD) for 12 weeks. |
| Fesoterodine | DRUG | The fesoterodine treatment will start with 4 mg once daily(QD) for 1 week followed by a forced dose-escalation to 8mg once daily(QD) for 11 weeks. |
| tolterodine tartrate | DRUG | 4 mg single dose of extended release capsules |
| Tolterodine | DRUG | Single dose per patient as determined by protocol. |
| Filling cystometry | PROCEDURE | This is a procedure. |
| Intravesical neurostimulation | PROCEDURE | This is a procedure. |
Inclusion Criteria: * Subjects with a diagnosis of overactive bladder. Exclusion Criteria: * Subjects with significant stress incontinence as determined by the investigator. * Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.
Tolterodine is used for overactive bladder, a condition marked by a sudden urge to urinate. It is being studied in patients with overactive bladder and urinary bladder overactivity. The drug is currently in Phase 3 clinical development for this indication.
Tolterodine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in treating overactive bladder.
Tolterodine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is a completed study comparing Tolterodine Extended Release to another medication in patients with overactive bladder.
Tolterodine has been studied in two completed clinical trials. The Phase 3 trial, NCT00611026, enrolled 2,417 patients with overactive bladder across multiple countries. A Phase 1 trial, NCT00481728, examined bladder sensation in 28 female healthy volunteers in Switzerland.
Tolterodine is not the same as Fesoterodine, though they are related. A clinical trial, NCT00611026, evaluated the efficacy and safety of Fesoterodine in comparison to Tolterodine Extended Release in patients with overactive bladder, indicating they are distinct medications being compared.