A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00645281

Purpose

The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: tolterodine extended release	Phase IV

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-Label, Single-Arm, Non-Randomized, Trial in Adult Patients With OAB.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OAB Bother Rating Scale at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
Change from baseline to Week 4 and 12 in micturition bladder diary variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to Week 4 and 12 in AUA Symptom Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to Week 4 and 12 in OAB questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression-Improvement at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To asses the safety of tolterodine in patients with OAB [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	896
Study Start Date:	March 2004
Study Completion Date:	January 2005

Arms	Assigned Interventions
tolterodine ER group: Experimental	Drug: tolterodine extended release Tolterodine ER capsule 4 mg daily for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

self-reported symptoms of OAB for ≥ 3 months prior to screening
OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
stress incontinence, functional, or overflow incontinence as determined by the investigator
symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
clinically significant urinary tract obstruction
history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
clinically significant interstitial cystitis or significant bladder pain syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645281

Show 96 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6121001
Study First Received:	March 25, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00645281 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Muscarinic Antagonists
Signs and Symptoms
Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele

Cholinergic Antagonists
Urologic Diseases
Urinary Bladder Diseases
Cholinergic Agents
Tolterodine

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Tolterodine

ClinicalTrials.gov processed this record on May 07, 2009