Phase 4 N=50 Randomized Treatment

A Preference Study Comparing Kristalose® and Liquid Lactulose

Constipation

Bottom Line

View on ClinicalTrials.gov: NCT00712543 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2011

Primary outcome: Primary: Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. — 7; 6; 12; 11 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: lactulose (Kristalose®) (Drug); liquid lactulose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cumberland Pharmaceuticals
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.	7; 6; 12; 11; 4; 8	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00712543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.