CEPHULAC

LOE Approaching

lactulose

NDAORAL, RECTALSOLUTIONPriority Review
Approved
Mar 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6

Mechanism of Action

CLINICAL PHARMACOLOGY Lactulose is poorly absorbed from the gastrointestinal tract and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue. As a result, oral doses of lactulose reach the colon virtually unchanged. In the colon, lactulose is broken down…

Clinical Trials (5)

NCT03666546Phase 4Completed

Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2

Started Nov 2018
24 enrolled
Diabetes Mellitus, Type 2
NCT03515044Phase 2Completed

Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Started Sep 2018
71 enrolled
Overt Hepatic Encephalopathy
NCT02968498N/ACompleted

Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers

Started Nov 2016
24 enrolled
Blood Glucose
NCT02377947N/ACompleted

A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]

Started Dec 2015
50 enrolled
Hepatic Encephalopathy
NCT02228616Phase 4Completed

Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation

Started Oct 2014
280 enrolled
Constipation