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NCT00712543 Clinical Trial

A Preference Study Comparing Kristalose® and Liquid Lactulose

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00712543
Other study ID # KR-001
Secondary ID
Status Completed
Phase Phase 4
First received July 8, 2008
Last updated August 19, 2011
Start date June 2009
Est. completion date September 2009

Study information
Verified date August 2011
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• lactulose (Kristalose®)
Crystals to be dissolved in water and taken as prescribed.
• liquid lactulose
Liquid to be taken as prescribed.

Locations
Country Name City State
United States Arya Gastroenterology Associates Brooklyn New York
United States Rapid Medical Research Cleveland Ohio
United States Wake Research Associates Raleigh North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. 14 days No
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