A Preference Study Comparing Kristalose® and Liquid Lactulose - Full Text View

Sponsor:	Cumberland Pharmaceuticals
Information provided by:	Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00712543

Purpose

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

Condition	Intervention	Phase
Constipation	Drug: lactulose (Kristalose®) Drug: liquid lactulose	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Lactulose

U.S. FDA Resources

Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:

To determine patient preference for the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine patient preference for the taste of the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
To determine patient preference for the consistency of the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
To determine patient preference for the portability of the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Kristalose®, as prescribed, for 7 days.	Drug: lactulose (Kristalose®) Crystals to be dissolved in water and taken as prescribed.
2: Experimental Liquid lactulose, as prescribed, for 7 days.	Drug: liquid lactulose Liquid to be taken as prescribed.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712543

Locations

United States, New York
Arya Gastroenterology Associates
Brooklyn, New York, United States, 11237
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122

Sponsors and Collaborators

Cumberland Pharmaceuticals

More Information

No publications provided

Responsible Party:	Cumberland Pharmaceuticals Inc. ( Amy Rock PhD, Senior Manager, Regulatory Affairs )
Study ID Numbers:	KR-001
Study First Received:	July 8, 2008
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00712543 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Cumberland Pharmaceuticals:

constipation
laxative
lactulose
Kristalose®

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Therapeutic Uses
Gastrointestinal Agents

Constipation
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on February 08, 2010