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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

January 28, 2009
December 2, 2010
April 2009
December 2009   (final data collection date for primary outcome measure)
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.
Safety measurement based on Adverse events, Vital signs and Clinical laboratory test. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00832650 on ClinicalTrials.gov Archive Site
  • 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.
  • Proximal colonic emptying rate, Colonic transit, Colonic filling and Gastric emptying time [ Time Frame: Day 12 to 14 ] [ Designated as safety issue: No ]
  • Number of stools per day [ Time Frame: Day -2 to 14 ] [ Designated as safety issue: No ]
  • Average score of stool consistency per day [ Time Frame: Day -2 to 14 ] [ Designated as safety issue: No ]
  • Average score of ease of passage during defecation per day [ Time Frame: Day -2 to 14 ] [ Designated as safety issue: No ]
  • Proportion of bowl movements with satisfaction per day [ Time Frame: Day -2 to 14 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: fesoterodine fumarate
    8 mg OD for 14 days
  • Drug: placebo
    OD for 14 days
  • Drug: solifenacin
    10 mg OD for 14 days
  • Experimental: Fesoterodine
    Tablets
    Intervention: Drug: fesoterodine fumarate
  • Placebo Comparator: Placebo
    Tablets
    Intervention: Drug: placebo
  • Active Comparator: Solifenacin
    Tablets
    Intervention: Drug: solifenacin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy female subjects

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832650
A0221057
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP