Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tegaserod

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No