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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00832650
• Other study ID #: A0221057
• Status: Terminated
• Phase: Phase 1
• First received: January 28, 2009
• Last updated: December 2, 2010
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00892034

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy female subjects

Exclusion Criteria:

• Evidence or history of clinically significant findings at screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• fesoterodine fumarate
8 mg OD for 14 days
• placebo
OD for 14 days
• solifenacin
10 mg OD for 14 days

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Proximal Colonic Emptying Time	Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.	Day 12 to 14	No
Secondary	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)	No
Secondary	Colonic Filling at 6 Hours	A surrogate marker of small bowel transit time.	Day 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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