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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

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ClinicalTrials.gov Identifier: NCT00646880
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: propiverine Drug: tolterodine PR Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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)
Study Start Date : March 2003
Study Completion Date : August 2003

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Parameters of detrusor activity, occurring throughout the duration of comparable AUM [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Number of pads used per 24 hours [ Time Frame: 28 days ]
  2. Urge Incontinence [ Time Frame: 28 days ]
  3. Number of urgency episodes [ Time Frame: 28 days ]
  4. Number of micturitions per 24 hours [ Time Frame: 28 days ]
  5. Volume voided per micturition [ Time Frame: 28 days ]
  6. Patient's perception of bladder condition [ Time Frame: 28 days ]
  7. Patient's perception of treatment benefit [ Time Frame: 28 days ]
  8. Patient's perception of urgency [ Time Frame: 28 days ]
  9. The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period. [ Time Frame: 42 days ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00646880     History of Changes
Other Study ID Numbers: DETAOD-0084-055
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Propiverine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents