A Preference Study Comparing Kristalose® and Liquid Lactulose

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arya Gastroenterology Associates, Brooklyn, New York, United States

About this study

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with recently diagnosed chronic constipation requiring treatment.

Exclusion criteria

Patients with galactosemia (galactose-sensitive diet).
Patients less than 18 years of age.
Patients currently on lactulose therapy.
Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.

Treatment and study plan

lactulose (Kristalose®)

Drug

Crystals to be dissolved in water and taken as prescribed.

Other names: Kristalose®

liquid lactulose

Drug

Liquid to be taken as prescribed.

Primary outcomes

Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.

Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 10, 2008
Registry last updated: Sep 27, 2011

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