A Preference Study Comparing Kristalose® and Liquid Lactulose

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: lactulose (Kristalose®); Drug: liquid lactulose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712543

KR-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

Kristalose®, as prescribed, for 7 days.

Treatment:

Drug: lactulose (Kristalose®)

2

Experimental group

Description:

Liquid lactulose, as prescribed, for 7 days.

Treatment:

Drug: liquid lactulose