Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

NCT ID: NCT00171522

Last Updated: 2016-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-09-30

Brief Summary

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To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tegaserod and Polyethylene Glycol 3350

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Females aged 18 to 64 years of age
* Patients with constipation as defined by the Rome II criteria

Exclusion Criteria

* Patients who have been previously been treated with tegaserod and/or PEG 3350
* Evidence of cathartic colon or a history of laxative abuse or laxative dependence
* History of fecal impaction which necessitated surgical intervention
* Patients with clinically significant abnormal TSH levels at screening
* Women who are pregnant or breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Locations

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Harmony Clinical Research

Oro Valley, Arizona, United States

Site Status

Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, United States

Site Status

Adobe Gastroenterology, PC

Tucson, Arizona, United States

Site Status

Associated Pharmaceutical Research Center, Inc

Buena Park, California, United States

Site Status

Clinical Trial Management of Boca Raton, Inc.

Boca Raton, Florida, United States

Site Status

Health Science Center

Pratt, Kansas, United States

Site Status

Beth Israel Deacon Medical Center

Boston, Massachusetts, United States

Site Status

Heartland Clinical Research, Inc

Omaha, Nebraska, United States

Site Status

MBS Clinical Research, LLC

Margate City, New Jersey, United States

Site Status

Midwest Clinical Research

Bellbrook, Ohio, United States

Site Status

Associates in Gastroenterology

Hermitage, Tennessee, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

National Clinical Research, Inc

Richmond, Virginia, United States

Site Status

East Coast Clinical Research

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CHTF919EUS49

Identifier Type: -

Identifier Source: org_study_id

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