A Preference Study Comparing Kristalose® and Liquid Lactulose

Cumberland Pharmaceuticals50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Constipation

Interventions

lactulose (Kristalose®)DRUG

Crystals to be dissolved in water and taken as prescribed.

liquid lactuloseDRUG

Liquid to be taken as prescribed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (3)

Arya Gastroenterology Associates

Brooklyn, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

Rapid Medical Research

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 14 days

Data from ClinicalTrials.gov

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