Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

Phase 4

Completed

• Conditions: Constipation

• Registration Number: NCT00171522
• Lead Sponsor: Novartis

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (14)

Harmony Clinical Research; 🇺🇸 Oro Valley, Arizona, United States

Central Phoenix Medical Clinic, LLC; 🇺🇸 Phoenix, Arizona, United States

Adobe Gastroenterology, PC; 🇺🇸 Tucson, Arizona, United States

Associated Pharmaceutical Research Center, Inc; 🇺🇸 Buena Park, California, United States

Clinical Trial Management of Boca Raton, Inc.; 🇺🇸 Boca Raton, Florida, United States

Health Science Center; 🇺🇸 Pratt, Kansas, United States

Beth Israel Deacon Medical Center; 🇺🇸 Boston, Massachusetts, United States

Heartland Clinical Research, Inc; 🇺🇸 Omaha, Nebraska, United States

MBS Clinical Research, LLC; 🇺🇸 Margate, New Jersey, United States

Midwest Clinical Research; 🇺🇸 Bellbrook, Ohio, United States

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