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

This study has been terminated.
(Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00832650
First received: January 28, 2009
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: fesoterodine fumarate
Drug: placebo
Drug: solifenacin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Colonic Transit at 24 Hours [ Time Frame: Day 13 (Day 12 24 hours post-meal) ] [ Designated as safety issue: No ]
    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:
  • Proximal Colonic Emptying Time [ Time Frame: Day 12 to 14 ] [ Designated as safety issue: No ]
    Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.

  • Colonic Transit at 48 Hours [ Time Frame: Day 14 (Day 12 48 hours post-meal) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 12 ] [ Designated as safety issue: No ]
    A surrogate marker of small bowel transit time.

  • Time to Gastric Emptying [ Time Frame: Day 12: 2 hours, 4 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 11 to 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 11 to 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 11 to 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 11 to 13 ] [ Designated as safety issue: No ]
    The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.


Enrollment: 60
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine
Tablets
Drug: fesoterodine fumarate
8 mg OD for 14 days
Placebo Comparator: Placebo
Tablets
Drug: placebo
OD for 14 days
Active Comparator: Solifenacin
Tablets
Drug: solifenacin
10 mg OD for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female subjects

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832650

Locations
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00832650     History of Changes
Obsolete Identifiers: NCT00892034
Other Study ID Numbers: A0221057
Study First Received: January 28, 2009
Results First Received: December 2, 2010
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy; Fesoterodine; Solifenacin

Additional relevant MeSH terms:
Fesoterodine
Solifenacin
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014