Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
Overview
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste
Full Title of Study: “A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
Interventions
- Drug: Tegaserod and Polyethylene Glycol 3350
Clinical Trial Outcome Measures
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)
Participating in This Clinical Trial
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: Female
Minimum Age: 18 Years
Maximum Age: 64 Years
Investigator Details
- Lead Sponsor
- Novartis
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