Status:

COMPLETED

A Preference Study Comparing Kristalose® and Liquid Lactulose

Lead Sponsor:

Cumberland Pharmaceuticals

Conditions:

Constipation

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

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

Detailed Description

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

Eligibility Criteria

Inclusion

  • Patients with recently diagnosed chronic constipation requiring treatment.

Exclusion

  • 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.

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00712543

Start Date

June 1 2009

End Date

September 1 2009

Last Update

September 27 2011

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Arya Gastroenterology Associates

Brooklyn, New York, United States, 11237

2

Wake Research Associates

Raleigh, North Carolina, United States, 27612

3

Rapid Medical Research

Cleveland, Ohio, United States, 44122