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NCT00171522 Clinical Trial

Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171522
Other study ID # CHTF919EUS49
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated March 2, 2016
Start date May 2005
Est. completion date September 2005

Study information
Verified date March 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tegaserod and Polyethylene Glycol 3350

Locations
Country Name City State
United States Midwest Clinical Research Bellbrook Ohio
United States Clinical Trial Management of Boca Raton, Inc. Boca Raton Florida
United States Beth Israel Deacon Medical Center Boston Massachusetts
United States Associated Pharmaceutical Research Center, Inc Buena Park California
United States Associates in Gastroenterology Hermitage Tennessee
United States R/D Clinical Research, Inc. Lake Jackson Texas
United States MBS Clinical Research, LLC Margate New Jersey
United States Heartland Clinical Research, Inc Omaha Nebraska
United States Harmony Clinical Research Oro Valley Arizona
United States Central Phoenix Medical Clinic, LLC Phoenix Arizona
United States Health Science Center Pratt Kansas
United States National Clinical Research, Inc Richmond Virginia
United States Adobe Gastroenterology, PC Tucson Arizona
United States East Coast Clinical Research Virginia Beach Virginia

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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