Preference of Tegaserod vs. PEG 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Tegaserod and Polyethylene Glycol 3350
Outcome Measures for this Clinical Trial
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.
Criteria for Participation 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 for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171522
