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Sponsors and Collaborators: |
Mayo Clinic Pfizer |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00892034 |
This study is being done to evaluate the effect of fesoterodine 4 mg and 8 mg as compared to placebo on the speed at which food travels through the stomach, intestines and colon. Sustained release fesoterodine and solifenacin are both FDA-approved for the treatment of overactive bladder.
Condition | Intervention | Phase |
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Healthy Volunteers |
Drug: 8 mg Fesoterodine SR tablet and matched 10 mg Solifenacin (Vesicare) placebo tablet Drug: Matched 8 mg placebo tablet and 10 mg solifenacin (Vesicare) tablets Drug: Placebo + Placebo tablets |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate the Effects of 8 mg Fesoterodine SR Tablets and 10 mg Solifenacin Tablet on Gastrointestinal Transit in Healthy Female Subjects |
Estimated Enrollment: | 200 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Fesoterodine + placebo: Experimental |
Drug: 8 mg Fesoterodine SR tablet and matched 10 mg Solifenacin (Vesicare) placebo tablet
8 mg Fesoterodine SR tablet and matched 10 mg Solifenacin (Vesicare) placebo tablet once daily by mouth.
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placebo + solifenacin: Experimental |
Drug: Matched 8 mg placebo tablet and 10 mg solifenacin (Vesicare) tablets
Matched 8 mg placebo tablet and 10 mg solifenacin (Vesicare) tablets once daily by mouth
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Placebo + Placebo: Placebo Comparator |
Drug: Placebo + Placebo tablets
Placebo + Placebo tablets once daily by mouth
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Constipation is a dose-related side-effect of many antimuscarinic agents used to treat overactive bladder. Data suggests that incidence of constipation is higher with M3 selective (eg, darifenacin) rather than nonselective muscarinic antagonists (eg, tolterodine and/or fesoterodine). Recent evidence suggests that tolterodine does not have clinically significant effects on GI transit in healthy subjects.
However, the effects of fesoterodine on GI transit are unknown. Since chronic constipation is a common symptoms, can significantly impair quality of life, and is associated with urinary urgency, it is important to understand the effects of anticholinergic agents on gastrointestinal transit in healthy subjects.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Use of the following medication for specified duration prior to enrollment:
Selective serotonin reuptake inhibitors (eg, fluoxetine, paroxetine) within six weeks prior to enrollment.
d. Opiates (eg, oxycodone) or medication containing morphine or codeine within one month prior to enrollment.
Contact: Adil E Bharucha, M.D. | 507-538-5854 |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Adil E Bharucha, M.D. 507-538-5854 | |
Principal Investigator: Adil E Bharucha, M.D. | |
Sub-Investigator: Karthik Ravi, M.D. |
Principal Investigator: | Adil E. Bharucha, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Adil Bharucha, M.D. ) |
Study ID Numbers: | 09-000944, A0221057 |
Study First Received: | May 1, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00892034 History of Changes |
Health Authority: | United States: Institutional Review Board |
healthy volunteer fesoterodine solifenacin gastrointestinal transit |
Muscarinic Antagonists Neurotransmitter Agents Cholinergic Antagonists |
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Healthy Cholinergic Agents |
Muscarinic Antagonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists |
Physiological Effects of Drugs Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Cholinergic Agents Pharmacologic Actions |