Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Chronic Constipation

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 safet...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2004

Trial Type :

INTERVENTIONAL

End Date :

February 1 2005

Estimated Enrollment :

1026 Patients enrolled

Trial Details

Trial ID

NCT00141089

Start Date

March 1 2004

End Date

February 1 2005

Last Update

February 1 2008

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