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 ]

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Measure Type	Primary
Measure Title	Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Measure Description	No text entered.
Time Frame	14 days
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Measured Values

	Powder, Then Liquid Lactulose	Liquid, Then Powder Lactulose
Number of Participants Analyzed [units: participants]	23	27
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. [units: participants]
Preferred liquid lactulose overall	7	6
Preferred powder lactulose overall	12	11
No preference overall	4	8
Preferred liquid lactulose in terms of taste	7	9
Preferred powder lactulose in terms of taste	12	11
No preference in terms of taste	4	5
Preferred liquid lactulose in terms of consistency	7	7
Preferred powder lactulose in terms of consistency	11	11
No preference in terms of consistency	5	7
Preferred liquid lactulose in terms of portability	1	4
Preferred powder lactulose in terms of portability	17	16
No preference in terms of portability	5	5

No statistical analysis provided for Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.

Serious Adverse Events

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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

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