Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00171522

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: Tegaserod and Polyethylene Glycol 3350	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation

Study Start Date :

May 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Female

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

Locations

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