A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

NCT ID: NCT00768521

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-03
• Study Completion Date: 2009-01-19

Brief Summary

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo

Group Type: EXPERIMENTAL

tolterodine tartrate

Intervention Type: DRUG

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule

Comparator: Placebo to tolterodine tartrate

Intervention Type: DRUG

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

2

Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)

Group Type: EXPERIMENTAL

tolterodine tartrate

Intervention Type: DRUG

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule

Comparator: Placebo to tolterodine tartrate

Intervention Type: DRUG

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

3

Part II, Sequence 1: study drug crossing over to placebo

Group Type: EXPERIMENTAL

tolterodine tartrate

Intervention Type: DRUG

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule

Comparator: Placebo to tolterodine tartrate

Intervention Type: DRUG

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

4

Part II, Sequence 2: placebo crossing over to study drug

Group Type: EXPERIMENTAL

tolterodine tartrate

Intervention Type: DRUG

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule

Comparator: Placebo to tolterodine tartrate

Intervention Type: DRUG

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Interventions

tolterodine tartrate

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule

Intervention Type: DRUG

Comparator: Placebo to tolterodine tartrate

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is a postmenopausal female 40 to 75 years of age
• Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2
• Patient has a documented history of overactive bladder for at least 6 months prior to screening

Exclusion Criteria

• Patient has stress or mixed incontinence
• Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
• Patient has a history of stroke, seizures, or major neurological disorders
• Patient has a history of fecal incontinence
• Patient has a history of continual urine leakage
• Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start
• Patient received bladder training of electrostimulation within 2 weeks of study start
• Patient requires a catheter
• Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
• Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
• Patient has been on hormone replacement therapy for less than 12 weeks at study start
• Patient must take medication for arrhythmia
• Patient consumes more than 2 alcoholic beverages per day
• Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine)
• Patient has multiple and/or severe allergies to foods and drugs
• Patient regularly uses any illegal drugs

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Frenkl T, Railkar R, Shore N, Bailen J, Sutherland S, Burke J, Scott BB, Ruddy M, Beals C. Evaluation of an experimental urodynamic platform to identify treatment effects: a randomized, placebo-controlled, crossover study in patients with overactive bladder. Neurourol Urodyn. 2012 Jan;31(1):69-74. doi: 10.1002/nau.21094. Epub 2011 Sep 8.

Reference Type: DERIVED

PMID: 21905086 (View on PubMed)

Other Identifiers

2008_560

Identifier Type: -

Identifier Source: secondary_id

0000-107

Identifier Type: -

Identifier Source: org_study_id