Chronic Constipation
Conditions
Keywords
Male patients, chronic constipation, tegaserod
Brief summary
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study was to evaluate the efficacy and safety of tegaserod on bowel habits in male patients with chronic constipation.
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
Inclusion criteria
* A 6-month history of constipation defined as \<3 complete spontaneous bowel movements per week and \>1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining
Exclusion criteria
* Patients with cancer, inflammatory bowel disease or other structural bowel disease * Past or current diagnosis of irritable bowel syndrome were excluded. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with mean increase of more than one complete spontaneous bowel movement (csbm) per week during the first 4 weeks of treatment compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| For csbm and sbm : Increase of > or = of one/week for weeks 1 to 12 and week 1, absolute number for week 1 to 4 and 1 to 12, time to 1st csbm, sbm. | — |
| Daily assessment of bowel habits, patients assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life, laxative use. | — |
| Safety and tolerability. | — |
Outcome results
None listed