Constipation Clinical Trial
Official title:
A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation
Verified date | March 2016 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste
Status | Completed |
Enrollment | 52 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 64 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Midwest Clinical Research | Bellbrook | Ohio |
United States | Clinical Trial Management of Boca Raton, Inc. | Boca Raton | Florida |
United States | Beth Israel Deacon Medical Center | Boston | Massachusetts |
United States | Associated Pharmaceutical Research Center, Inc | Buena Park | California |
United States | Associates in Gastroenterology | Hermitage | Tennessee |
United States | R/D Clinical Research, Inc. | Lake Jackson | Texas |
United States | MBS Clinical Research, LLC | Margate | New Jersey |
United States | Heartland Clinical Research, Inc | Omaha | Nebraska |
United States | Harmony Clinical Research | Oro Valley | Arizona |
United States | Central Phoenix Medical Clinic, LLC | Phoenix | Arizona |
United States | Health Science Center | Pratt | Kansas |
United States | National Clinical Research, Inc | Richmond | Virginia |
United States | Adobe Gastroenterology, PC | Tucson | Arizona |
United States | East Coast Clinical Research | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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