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Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.

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Novartis

Status and phase

Completed
Phase 3

Conditions

Chronic Constipation

Treatments

Drug: Tegaserod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141089
CHTF919E2309

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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