Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

Study Overview
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Brief Summary
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To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: fesoterodine fumarate
* Drug: placebo
* Drug: solifenacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female subjects Exclusion Criteria: Evidence or history of clinically significant findings at screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fesoterodine<br>Tablets | Drug: fesoterodine fumarate<br>* 8 mg OD for 14 days<br>|
| Placebo Comparator: Placebo<br>Tablets | Drug: placebo<br>* OD for 14 days<br>|
| Active Comparator: Solifenacin<br>Tablets | Drug: solifenacin<br>* 10 mg OD for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic Transit at 24 Hours | Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100. | Day 13 (Day 12 24 hours post-meal) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal Colonic Emptying Time | Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. | Day 12 to 14 | 
| Colonic Transit at 48 Hours | Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100. | Day 14 (Day 12 48 hours post-meal) | 
| Colonic Filling at 6 Hours | A surrogate marker of small bowel transit time. | Day 12 | 
| Time to Gastric Emptying | Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. | Day 12: 2 hours, 4 hours | 
| Mean Number of Stools Per Day | Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days. | Day 11 to 13 | 
| Mean Score of Stool Consistency Per Day | Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery). | Day 11 to 13 | 
| Average Score of Ease of Passage During Defecation Per Day | Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent). | Day 11 to 13 | 
| Mean Proportion of Bowel Movements With Satisfaction Per Day | The number of stools with satisfaction of Yes divided by the total number of stools passed on each notional day. Mean of 3 days. | Day 11 to 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy; Fesoterodine; Solifenacin