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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Tegaserod and Polyethylene Glycol 3350

Primary 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 Measures

• n.a.

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171522

Study ID Number: CHTF919EUS49

ClinicalTrials.gov Identifier: NCT00171522

Health Authority: United States: Food and Drug Administration