A Preference Study Comparing Kristalose® and Liquid Lactulose
Information source: Cumberland Pharmaceuticals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation
Intervention: lactulose (Kristalose®) (Drug); liquid lactulose (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Cumberland Pharmaceuticals
Summary
This study will evaluate whether patients have an overall preference for Kristalose® or
liquid lactulose based on taste, consistency, and portability.
Clinical Details
Official title: A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation
Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Primary outcome: To determine patient preference for the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire.
Secondary outcome: To determine patient preference for the taste of the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire.To determine patient preference for the consistency of the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire. To determine patient preference for the portability of the powder or liquid form of lactulose, as demonstrated by patients responses on a questionnaire.
Detailed description:
This study will evaluate whether patients have an overall preference for Kristalose® or
liquid lactulose based on taste, consistency, and portability.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2009
Last updated: January 8, 2009
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