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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00832650
First received: January 28, 2009
Last updated: December 2, 2010
Last verified: December 2010
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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 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:
|
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013