Trial Outcomes & Findings for Study of Lactulose in Children With Chronic Liver Disease (NCT NCT00811434)

NCT ID: NCT00811434

Last Updated: 2014-02-10

Results Overview

failure of one cognitive function test indicates presence of MHE

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: baseline
• Results posted on: 2014-02-10

Participant Flow

Informed consent was obtained on the first subject 1/16/2009 and recruitment continued until study closure in November 2010.

Two subjects were withdrawn prior to randomization.Two did not meet entry criteria.

Participant milestones

Measure	Lactulose First, Then Placebo Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day	Placebo First, Then Lactulose Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight
First Intervention STARTED	7	5
First Intervention COMPLETED	4	5
First Intervention NOT COMPLETED	3	0
Washout (1 Month) STARTED	4	5
Washout (1 Month) COMPLETED	4	5
Washout (1 Month) NOT COMPLETED	0	0
Second Intervention STARTED	4	5
Second Intervention COMPLETED	4	5
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Lactulose in Children With Chronic Liver Disease

Baseline characteristics by cohort

Measure	All Participants n=12 Participants all aprticipants who were randomized to receive treatment
Age, Categorical <=18 years	12 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

failure of one cognitive function test indicates presence of MHE

Outcome measures

Measure	All Randomized Participants n=12 Participants	Placebo 1.5 ml/kg day po of sugar water placebo for three months
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis	6 participant	—

SECONDARY outcome

Timeframe: baseline

Population: data not collected as planned

HRQOL administered to parents prior to treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: before and after each treatment period

Population: data not collected as planned

MHE as measured by failure of one or more cognitive test

Outcome measures

Outcome data not reported

Adverse Events

Lactulose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Girish Subbarao

Riley Hospital

Phone: 317-944-3774

Email: gsrao@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place