A Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic Monitoring

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00646880
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: propiverine
Drug: tolterodine PR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Parameters of detrusor activity, occurring throughout the duration of comparable AUM [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of pads used per 24 hours [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Urge Incontinence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of urgency episodes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of micturitions per 24 hours [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Volume voided per micturition [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Patient's perception of bladder condition [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Patient's perception of treatment benefit [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Patient's perception of urgency [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: March 2003
Study Completion Date: August 2003
Arms Assigned Interventions
Active Comparator: Propiverine/tolterodine group Drug: propiverine
Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.
Active Comparator: Tolerodine/propiverine group Drug: tolterodine PR
Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of urinary urgency
  • Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart
  • Symptoms of overactive bladder for greater than or equal to 6 months

Exclusion Criteria:

  • Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
  • An average volume voided of >200 ml per micturition as verified on the micturition chart before randomization
  • Total daily urine volume of >3000 ml as verified on the micturition chart before randomization
  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: NCT00646880

Locations
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
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: NCT00646880     History of Changes
Other Study ID Numbers: DETAOD-0084-055
Study First Received: March 26, 2008
Last Updated: March 28, 2008
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014