Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation
1 other identifier
interventional
52
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2005
Shorter than P25 for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedMarch 3, 2016
March 1, 2016
September 12, 2005
March 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Interventions
Eligibility Criteria
You may qualify if:
- Females aged 18 to 64 years of age
- Patients with constipation as defined by the Rome II criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (14)
Harmony Clinical Research
Oro Valley, Arizona, 85739, United States
Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, 85201, United States
Adobe Gastroenterology, PC
Tucson, Arizona, 85712, United States
Associated Pharmaceutical Research Center, Inc
Buena Park, California, 90620, United States
Clinical Trial Management of Boca Raton, Inc.
Boca Raton, Florida, 33486, United States
Health Science Center
Pratt, Kansas, 67124, United States
Beth Israel Deacon Medical Center
Boston, Massachusetts, 02215, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134, United States
MBS Clinical Research, LLC
Margate City, New Jersey, 08402, United States
Midwest Clinical Research
Bellbrook, Ohio, 45305, United States
Associates in Gastroenterology
Hermitage, Tennessee, 37076, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
East Coast Clinical Research
Virginia Beach, Virginia, 23454, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
May 1, 2005
Study Completion
September 1, 2005
Last Updated
March 3, 2016
Record last verified: 2016-03