Back to resultsA Preference Study Comparing Kristalose® and Liquid Lactulose
Primary Purpose
Constipation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lactulose (Kristalose®)
liquid lactulose
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring constipation, laxative, lactulose, Kristalose®
Eligibility 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.
Sites / Locations
- Arya Gastroenterology Associates
- Wake Research Associates
- Rapid Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Kristalose®, as prescribed, for 7 days.
Liquid lactulose, as prescribed, for 7 days.
Outcomes
Primary Outcome Measures
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Secondary Outcome Measures
Full Information
NCT ID
NCT00712543
First Posted
July 8, 2008
Last Updated
August 19, 2011
Sponsor
Cumberland Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00712543
Brief Title
A Preference Study Comparing Kristalose® and Liquid Lactulose
Official Title
A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cumberland Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Detailed Description
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, laxative, lactulose, Kristalose®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Kristalose®, as prescribed, for 7 days.
Arm Title
2
Arm Type
Experimental
Arm Description
Liquid lactulose, as prescribed, for 7 days.
Intervention Type
Drug
Intervention Name(s)
lactulose (Kristalose®)
Other Intervention Name(s)
Kristalose®
Intervention Description
Crystals to be dissolved in water and taken as prescribed.
Intervention Type
Drug
Intervention Name(s)
liquid lactulose
Intervention Description
Liquid to be taken as prescribed.
Primary Outcome Measure Information:
Title
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Arya Gastroenterology Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11237
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Preference Study Comparing Kristalose® and Liquid Lactulose
We'll reach out to this number within 24 hrs