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A Preference Study Comparing Kristalose® and Liquid Lactulose

This study has been completed.
Sponsor:
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
History of Changes
Results First Received: April 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Constipation
Interventions: Drug: lactulose (Kristalose®)
Drug: liquid lactulose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited from the outpaient clinics of Wake Research Associates (Raleigh, NC); Rapid Medical Research (Cleveland, OH) and Arya Gastroenterology (Brooklyn, NY) between June 2009 and August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Powder, Then Liquid Lactulose Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
Liquid, Then Powder Lactulose Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.

Participant Flow for 2 periods

 Period 1:   Day 1-7
    Powder, Then Liquid Lactulose     Liquid, Then Powder Lactulose  
STARTED     23     27  
COMPLETED     23     27  
NOT COMPLETED     0     0  

Period 2:   Day 8-14
    Powder, Then Liquid Lactulose     Liquid, Then Powder Lactulose  
STARTED     23     27  
COMPLETED     23     25  
NOT COMPLETED     0     2  
Lost to Follow-up                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Powder, Then Liquid Lactulose Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
Liquid, Then Powder Lactulose Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.
Total Total of all reporting groups

Baseline Measures
    Powder, Then Liquid Lactulose     Liquid, Then Powder Lactulose     Total  
Number of Participants  
[units: participants]
 		  23     27     50  
Age, Customized  
[units: years]
Mean ± Standard Deviation 		  44.02  ± 13.37     52.37  ± 15.71     48.61  ± 14.95  
Gender  
[units: participants]
 		     
Female     18     19     37  
Male     5     8     13  
Race/Ethnicity, Customized  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     15     11     26  
White     3     10     13  
Hispanic     4     5     9  
Other     1     0     1  



  Outcome Measures

1.  Primary:   Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.   [ Time Frame: 14 days ]
  Show Outcome Measure 1


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Powder, Then Liquid Lactulose Kristalose (powder lactulose), as perscribed, for the first 7 days, then liquid lactulose (as perscribed) for the second 7 days.
Liquid, Then Powder Lactulose Liquid lactulose, as perscribed, for the first 7 days, then Kristalose (powder lactulose), as perscribed, for the second 7 days.

Serious Adverse Events
    Powder, Then Liquid Lactulose     Liquid, Then Powder Lactulose  
Total, serious adverse events      
# participants affected / at risk     0/50 (0.00%)     0/50 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Bryan Voss, Ph.D.
Organization: Cumberland Pharmaceuticals Inc.
phone: 615-255-0068
e-mail: bvoss@cumberlandpharma.com


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