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

Sponsored by:	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

MedlinePlus related topics: Constipation

Drug Information available for: Amphetamine Lactulose Methamphetamine

U.S. FDA Resources

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

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:	April 2009
Estimated Primary Completion Date:	December 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

No Contacts or Locations Provided

More Information

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:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00712543
Health Authority:	United States: Institutional Review Board

Keywords provided by Cumberland Pharmaceuticals:

constipation
laxative
lactulose
Kristalose®

Study placed in the following topic categories:

Signs and Symptoms
Methamphetamine
Signs and Symptoms, Digestive

Constipation
Amphetamine
Lactulose

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009