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Sponsored by: |
Cumberland Pharmaceuticals |
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Information provided by: | Cumberland Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00712543 |
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Condition | Intervention | Phase |
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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 |
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 |
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1: Experimental
Kristalose®, as prescribed, for 7 days.
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Drug: lactulose (Kristalose®)
Crystals to be dissolved in water and taken as prescribed.
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2: Experimental
Liquid lactulose, as prescribed, for 7 days.
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Drug: liquid lactulose
Liquid to be taken as prescribed.
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This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
constipation laxative lactulose Kristalose® |
Signs and Symptoms Methamphetamine Signs and Symptoms, Digestive |
Constipation Amphetamine Lactulose |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |