A Preference Study Comparing Kristalose® and Liquid Lactulose

This study has been completed.

Study NCT00712543 Information provided by Cumberland Pharmaceuticals

First Received on July 8, 2008. Last Updated on August 19, 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
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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.

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.

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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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
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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