Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 52
- Females aged 18 to 64 years of age
- Patients with constipation as defined by the Rome II 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Beth Israel Deacon Medical Center
🇺🇸Boston, Massachusetts, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Heartland Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
MBS Clinical Research, LLC
🇺🇸Margate, New Jersey, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
East Coast Clinical Research
🇺🇸Virginia Beach, Virginia, United States
Clinical Trial Management of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
Associated Pharmaceutical Research Center, Inc
🇺🇸Buena Park, California, United States
Midwest Clinical Research
🇺🇸Bellbrook, Ohio, United States
Health Science Center
🇺🇸Pratt, Kansas, United States
Harmony Clinical Research
🇺🇸Oro Valley, Arizona, United States
Central Phoenix Medical Clinic, LLC
🇺🇸Phoenix, Arizona, United States
Associates in Gastroenterology
🇺🇸Hermitage, Tennessee, United States
Adobe Gastroenterology, PC
🇺🇸Tucson, Arizona, United States