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

NCT00768521 | Completed Phase 1 Results

• 2 other identifiers: 0000-1072008_560
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo

  Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

  4 hours post dose 7

Secondary Outcomes (1)

• Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo

  4 hours post dose 1

Study Arms (4)

1

EXPERIMENTAL

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

Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate

2

EXPERIMENTAL

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

Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate

3

EXPERIMENTAL

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

Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate

4

EXPERIMENTAL

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

Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate

Interventions

tolterodine tartrate 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

1; 2; 3; 4

Comparator: Placebo to tolterodine tartrate 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

1; 2; 3; 4

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21905086 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Limitations and Caveats

The analysis presented includes all patients. An analysis excluding patients who were misdosed yielded different results with a similar conclusion and are not presented.

Results Point of Contact

• Title: Executive Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: September 3, 2008
• Primary Completion: January 19, 2009
• Study Completion: January 19, 2009
• Last Updated: February 22, 2018
• Results First Posted: August 19, 2014

Record last verified: 2018-01