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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Rochester, Minnesota, 55905 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant findings at screening

NCT00832650
Pfizer
Terminated
Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00832650
A0221057
No
Not Provided
Not Provided
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

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