Back to resultsPreference of Tegaserod vs. PEG 3350 in Patients With Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tegaserod and Polyethylene Glycol 3350
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Constipation, Tegaserod, Polyethylene Glycol 3350, PEG
Eligibility Criteria
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
Sites / Locations
- Harmony Clinical Research
- Central Phoenix Medical Clinic, LLC
- Adobe Gastroenterology, PC
- Associated Pharmaceutical Research Center, Inc
- Clinical Trial Management of Boca Raton, Inc.
- Health Science Center
- Beth Israel Deacon Medical Center
- Heartland Clinical Research, Inc
- MBS Clinical Research, LLC
- Midwest Clinical Research
- Associates in Gastroenterology
- R/D Clinical Research, Inc.
- National Clinical Research, Inc
- East Coast Clinical Research
Outcomes
Primary Outcome 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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171522
Brief Title
Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
Official Title
A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation, Tegaserod, Polyethylene Glycol 3350, PEG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tegaserod and Polyethylene Glycol 3350
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Harmony Clinical Research
City
Oro Valley
State/Province
Arizona
ZIP/Postal Code
85739
Country
United States
Facility Name
Central Phoenix Medical Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
Adobe Gastroenterology, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Associated Pharmaceutical Research Center, Inc
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Clinical Trial Management of Boca Raton, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Health Science Center
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Beth Israel Deacon Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Heartland Clinical Research, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
MBS Clinical Research, LLC
City
Margate
State/Province
New Jersey
ZIP/Postal Code
08402
Country
United States
Facility Name
Midwest Clinical Research
City
Bellbrook
State/Province
Ohio
ZIP/Postal Code
45305
Country
United States
Facility Name
Associates in Gastroenterology
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
East Coast Clinical Research
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
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