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

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.

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

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: fesoterodine fumarate; Drug: placebo; Drug: solifenacin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy female subjects

Exclusion Criteria:

• Evidence or history of clinically significant findings at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Tablets	Drug: placebo; OD for 14 days
Experimental: Fesoterodine; Tablets	Drug: fesoterodine fumarate; 8 mg OD for 14 days
Active Comparator: Solifenacin; Tablets	Drug: solifenacin; 10 mg OD for 14 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Bharucha AE, Isowa H, Hiro S, Guan Z. Differential effects of selective and non-selective muscarinic antagonists on gastrointestinal transit and bowel function in healthy women. Neurogastroenterol Motil. 2013 Jan;25(1):e35-43. doi: 10.1111/nmo.12043. Epub 2012 Nov 21.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 28, 2009
• First Submitted That Met QC Criteria: January 28, 2009
• First Posted (Estimate): January 30, 2009

Study Record Updates

• Last Update Posted (Estimate): December 24, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Healthy; Fesoterodine; Solifenacin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate; Fesoterodine
• Other Study ID Numbers: A0221057