Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Status and phase
Completed
Phase 4
Conditions
Chronic Constipation
Treatments
Drug: Tegaserod
Details and patient eligibility
About
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male and females of at least 18 years of age
- A 12-month history of constipation (defined as < three 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
- Patients who participated in a prior tegaserod study
- Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
Other protocol-defined inclusion/exclusion criteria may apply.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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