A Preference Study Comparing Kristalose® and Liquid Lactulose
This study has been completed.
Sponsor:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00712543
First received: July 8, 2008
Last updated: August 19, 2011
Last verified: August 2011
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
- Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Kristalose®, as prescribed, for 7 days.
|
Drug: lactulose (Kristalose®)
Crystals to be dissolved in water and taken as prescribed.
Other Name: Kristalose®
|
|
Experimental: 2
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 |
| ClinicalTrials.gov Identifier: | NCT00712543 History of Changes |
| Other Study ID Numbers: | KR-001 |
| Study First Received: | July 8, 2008 |
| Results First Received: | April 7, 2011 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cumberland Pharmaceuticals:
|
constipation laxative lactulose Kristalose® |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Lactulose |
Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013