A Preference Study Comparing Kristalose® and Liquid Lactulose

NCT ID: NCT00712543

Last Updated: 2011-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-09-30

Brief Summary

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This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Detailed Description

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This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Kristalose®, as prescribed, for 7 days.

Group Type EXPERIMENTAL

lactulose (Kristalose®)

Intervention Type DRUG

Crystals to be dissolved in water and taken as prescribed.

2

Liquid lactulose, as prescribed, for 7 days.

Group Type EXPERIMENTAL

liquid lactulose

Intervention Type DRUG

Liquid to be taken as prescribed.

Interventions

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lactulose (Kristalose®)

Crystals to be dissolved in water and taken as prescribed.

Intervention Type DRUG

liquid lactulose

Liquid to be taken as prescribed.

Intervention Type DRUG

Other Intervention Names

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Kristalose®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arya Gastroenterology Associates

Brooklyn, New York, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

Rapid Medical Research

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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KR-001

Identifier Type: -

Identifier Source: org_study_id