Preference of Tegaserod vs. PEG 3350 in Patients With Constipation - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171522

Purpose

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

Condition	Intervention	Phase
Constipation	Drug: Tegaserod and Polyethylene Glycol 3350	Phase IV

MedlinePlus related topics: Constipation

Drug Information available for: Tegaserod Tegaserod maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation

Further study details as provided by Novartis:

Primary Outcome Measures:

To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)

Secondary Outcome Measures:

n.a.

Estimated Enrollment:	52
Study Start Date:	May 2005
Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Female

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171522

Locations

United States, Arizona
Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States, 85201
Harmony Clinical Research
Oro Valley, Arizona, United States, 85739
Adobe Gastroenterology, PC
Tucson, Arizona, United States, 85712
United States, California
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States, 90620
United States, Florida
Clinical Trial Management of Boca Raton, Inc.
Boca Raton, Florida, United States, 33486
United States, Kansas
Health Science Center
Pratt, Kansas, United States, 67124
United States, Massachusetts
Beth Israel Deacon Medical Center
Boston, Massachusetts, United States, 02215
United States, Nebraska
Heartland Clinical Research, Inc
Omaha, Nebraska, United States, 68134
United States, New Jersey
MBS Clinical Research, LLC
Margate, New Jersey, United States, 08402
United States, Ohio
Midwest Clinical Research
Bellbrook, Ohio, United States, 45305
United States, Tennessee
Associates in Gastroenterology
Hermitage, Tennessee, United States, 37076
United States, Texas
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
United States, Virginia
National Clinical Research, Inc
Richmond, Virginia, United States, 23294
East Coast Clinical Research
Virginia Beach, Virginia, United States, 23454

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CHTF919EUS49
Study First Received:	September 12, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00171522
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Constipation
Tegaserod
Polyethylene Glycol 3350
PEG

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Serotonin
Tegaserod

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents

Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009