Chronic Constipation
Conditions
Keywords
Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying
Brief summary
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
Interventions
DRUGTegaserod
Sponsors
Temple University
University of Michigan
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Inclusion criteria
* Male & Females aged 65 and older * Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks * Patients must have had a colonoscopy within the past 5 years * Patients must pass a balloon expulsion test at screening * Patients must be able to comply and understand the use of a diary
Exclusion criteria
* Patients with a clinically significant medical condition that would interfere with the patient completing the trial * Patients with loose stools at least once per week * Patients with IBS * Known allergies to the same class of drug and/or allergies to eggs * Patients who require the use of manual maneuvers to have a bowel movement Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy | — |
Secondary
| Measure | Time frame |
|---|---|
| Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy | — |
Countries
United States
Outcome results
None listed