Preference of Tegaserod vs. PEG 3350 in Patients With Constipation

To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste

Completed

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Harmony Clinical Research, Oro Valley, Arizona, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Females aged 18 to 64 years of age
Patients with constipation as defined by the Rome II criteria

Exclusion criteria

Patients who have been previously been treated with tegaserod and/or PEG 3350
Evidence of cathartic colon or a history of laxative abuse or laxative dependence
History of fecal impaction which necessitated surgical intervention
Patients with clinically significant abnormal TSH levels at screening
Women who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Tegaserod and Polyethylene Glycol 3350

Drug

Primary outcomes

To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation

Important dates

Study start: 2005
Study completion: 2005
First posted: Sep 15, 2005
Registry last updated: Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed