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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