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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: fesoterodine fumarate; Drug: placebo; Drug: solifenacin

• Registration Number: NCT00832650
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-30
• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-12
• Results First Submitted: 2010-12-02
• Results First Submitted QC: 2010-12-02
• Last Update Submitted: 2010-12-02
• Results First Posted: 2010-12-24
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Healthy female subjects

Exclusion Criteria

• Evidence or history of clinically significant findings at screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fesoterodine	fesoterodine fumarate	Tablets
Placebo	placebo	Tablets
Solifenacin	solifenacin	Tablets

Primary Outcome Measures

Name	Time	Method
Colonic Transit at 24 Hours	Day 13 (Day 12 24 hours post-meal)	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.

Secondary Outcome Measures

Name	Time	Method
Proximal Colonic Emptying Time	Day 12 to 14	Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Colonic Transit at 48 Hours	Day 14 (Day 12 48 hours post-meal)	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.
Colonic Filling at 6 Hours	Day 12	A surrogate marker of small bowel transit time.
Time to Gastric Emptying	Day 12: 2 hours, 4 hours	Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Mean Number of Stools Per Day	Day 11 to 13	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.
Mean Score of Stool Consistency Per Day	Day 11 to 13	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).
Average Score of Ease of Passage During Defecation Per Day	Day 11 to 13	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).
Mean Proportion of Bowel Movements With Satisfaction Per Day	Day 11 to 13	The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Rochester, Minnesota, United States