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

Phase 1TerminatedNCT00832650

Pfizer60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

fesoterodine fumarateDRUG

8 mg OD for 14 days

placeboDRUG

OD for 14 days

solifenacinDRUG

10 mg OD for 14 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 13 (Day 12 24 hours post-meal)

Secondary Outcomes

Proximal Colonic Emptying Time

Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.

Time frame: 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.

Time frame: Day 14 (Day 12 48 hours post-meal)

Colonic Filling at 6 Hours

A surrogate marker of small bowel transit time.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.