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
  Purpose

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


Condition Intervention Phase
Constipation
Drug: lactulose (Kristalose®)
Drug: liquid lactulose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

Resource links provided by NLM:


Further study details as provided by Cumberland Pharmaceuticals:

Primary Outcome Measures:
  • Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Kristalose®, as prescribed, for 7 days.
Drug: lactulose (Kristalose®)
Crystals to be dissolved in water and taken as prescribed.
Other Name: Kristalose®
Experimental: 2
Liquid lactulose, as prescribed, for 7 days.
Drug: liquid lactulose
Liquid to be taken as prescribed.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712543

Locations
United States, New York
Arya Gastroenterology Associates
Brooklyn, New York, United States, 11237
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
Sponsors and Collaborators
Cumberland Pharmaceuticals
  More Information

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

Keywords provided by Cumberland Pharmaceuticals:
constipation
laxative
lactulose
Kristalose®

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014