A Preference Study Comparing Kristalose® and Liquid Lactulose

August 19, 2011 updated by: Cumberland Pharmaceuticals

A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11237
        • Arya Gastroenterology Associates
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Kristalose®, as prescribed, for 7 days.
Drug: lactulose (Kristalose®)
Crystals to be dissolved in water and taken as prescribed.
Other Names:
  • Kristalose®
Experimental: 2
Liquid lactulose, as prescribed, for 7 days.
Drug: liquid lactulose
Liquid to be taken as prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumberland Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

August 19, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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