A Preference Study Comparing Kristalose® and Liquid Lactulose
1 other identifier
interventional
50
1 country
3
Brief Summary
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2009
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2008
CompletedFirst Posted
Study publicly available on registry
July 10, 2008
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
September 27, 2011
CompletedSeptember 27, 2011
August 1, 2011
3 months
July 8, 2008
April 7, 2011
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
14 days
Study Arms (2)
1
EXPERIMENTALKristalose®, as prescribed, for 7 days.
2
EXPERIMENTALLiquid lactulose, as prescribed, for 7 days.
Interventions
Crystals to be dissolved in water and taken as prescribed.
Eligibility Criteria
You may qualify if:
- Patients with recently diagnosed chronic constipation requiring treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Arya Gastroenterology Associates
Brooklyn, New York, 11237, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bryan Voss, Ph.D.
- Organization
- Cumberland Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2008
First Posted
July 10, 2008
Study Start
June 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
September 27, 2011
Results First Posted
September 27, 2011
Record last verified: 2011-08