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Carbinoxamine and Pseudoephedrine Extended-Release Tablets |
Coldec D Extended-Release Tablets; Palgic-D Extended-Release Tablets; Rondec-TR Tablets |
Clinical Trial: Evaluate Efficacy and Safety of Tolterodine Extended Release Capsule Compared with Tolterodine Immediate Release Tablet in Patients with Symptoms of Overactive Bladder
This study is currently recruiting patients.
Verified by Pfizer August 2005
|
Purpose
To evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder
| Condition | Intervention | Phase |
|---|---|---|
| Overactive bladder | Drug: tolterodine extended release capsule | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomized, Double-Blind, Double-Dummy, Multi-Center Study to Compare the Efficacy, Safety, and Tolerability of Tolterodine Extended Release Capsule with Tolterodine Immediate Release Tablet in Subjects with Symptoms of Overactive Bladder
Further Study Details:
Primary Outcomes: To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder
Secondary Outcomes: To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder. The other secondary endpoints include the change from baseline to 8
Expected Total Enrollment: 240
Secondary Outcomes: To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder. The other secondary endpoints include the change from baseline to 8
Expected Total Enrollment: 240
Study start: May 2005
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Subjects with a diagnosis of overactive bladder.
Exclusion Criteria:
-
Subjects with significant stress incontinence as determined by the investigator.
- Subjects with recurrent urinary tract infections defined as treated for UTI ³ 5 times in the last year.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00139724
Pfizer CT.gov Call Center 1-800-718-1021
China
Pfizer Investigational Site, Beijing, 100034, China; Recruiting
Pfizer Investigational Site, Shanghai, 200040, China; Recruiting
Pfizer Investigational Site, Shanghai, 200127, China; Recruiting
Pfizer Investigational Site, Chongqing, China; Recruiting
Pfizer Investigational Site, Beijing, 100034, China; Recruiting
Pfizer Investigational Site, Beijing, 100020, China; Recruiting
China, Zhejiang Province
Pfizer Investigational Site, Huangzhou, Zhejiang Province, 310003, China; Recruiting
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A6121112
Last Updated: August 30, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00139724
Health Authority: China: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: August 30, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00139724
Health Authority: China: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06
Resources
- Carbinoxamine and Pseudoephedrine Extended-Release Tablets (Drug Digest)
- Coldec D Extended-Release Tablets (Drug Digest)
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