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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645281
First received: March 25, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Experimental: tolterodine ER group 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014