Constipation
Conditions
Keywords
Chronic constipation, 5-HT,5-HT4,, functional GI, China, tegaserod
Brief summary
Tegaserod is an aminoguanidine indole compound and a member of a new class of 5-hydroxytryptamine (5-HT) agonists. Activation of 5-HT4 receptors triggers the release of neurotransmitters from the enteric nerves which in turn stimulate contractility and peristalsis. This study will investigate the efficacy and safety of tegaserod against chronic constipation in a Chinese population of adult men and women
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women at least 18 years of age * History of constipation for at least 6 months prior to screening * Normal bowel evaluation performed within the past 5 years
Exclusion criteria
* Most bothersome symptom in last 6 months is abdominal pain/discomfort * Whose chronic constipation is thought to be a result of bowel surgery, gynecological surgery, neurologic disorder, systemic sclerosis, amyloidosis, scleroderma, myotonic dystrophy * Insulin dependent diabetes * Evidence of cathartic colon or laxative abuse Other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in number of complete spontaneous bowel movements (CSBM) per week | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients' daily assessment of bowel habits | — |
| Patients' weekly assessment of constipation symptoms | — |
| Satisfactory relief of CC symptoms | — |
| Response rate for CSBM during the first 4 weeks of treatment | — |
| PPSM questionnaire | — |
| Safety | — |
| PAC-QoL questionnaire | — |
Countries
Switzerland
Outcome results
None listed