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

NCT ID: NCT00832650

Last Updated: 2010-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy; Fesoterodine; Solifenacin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fesoterodine

Tablets

Group Type EXPERIMENTAL

fesoterodine fumarate

Intervention Type DRUG

8 mg OD for 14 days

Placebo

Tablets

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

OD for 14 days

Solifenacin

Tablets

Group Type ACTIVE_COMPARATOR

solifenacin

Intervention Type DRUG

10 mg OD for 14 days

Interventions

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fesoterodine fumarate

8 mg OD for 14 days

Intervention Type DRUG

placebo

OD for 14 days

Intervention Type DRUG

solifenacin

10 mg OD for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female subjects

Exclusion Criteria

* Evidence or history of clinically significant findings at screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23171069 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221057&StudyName=Multiple%20Dose%20Study%20To%20Investigate%20The%20Effects%20Of%20Fesoterodine%20And%20Solifenacin%20On%20Gastrointestinal%20Transit

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0221057

Identifier Type: -

Identifier Source: org_study_id

NCT00892034

Identifier Type: -

Identifier Source: nct_alias