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| Sponsored by: |
Pfizer |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00481728 |
Purpose
Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.
| Condition | Intervention | Phase |
|
Overactive Bladder |
Drug: Tolterodine Procedure: Filling cystometry Procedure: Intravesical neurostimulation |
Phase I |
| ChemIDplus related topics: | Tolterodine Tolterodine tartrate |
| Study Type: | Interventional |
| Study Design: | Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study |
| Official Title: | Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers |
| Estimated Enrollment: | 28 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Tolterodine: Experimental |
Drug: Tolterodine
Single dose per patient as determined by protocol.
Procedure: Filling cystometry
This is a procedure.
Procedure: Intravesical neurostimulation
This is a procedure.
|
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
| Switzerland | |||||
| Pfizer Investigational Site | Recruiting | ||||
| Zurich, Switzerland, CH- 8008 | |||||
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
  |
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6121189 |
| First Received: | June 1, 2007 |
| Last Updated: | September 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00481728 |
| Health Authority: | Switzerland: Ethikkommision |
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