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NCT00811434 · ClinicalTrials.gov registry record · Phase 2
Study of Lactulose in Children With Chronic Liver Disease
A Phase 2 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00811434: Clinical Trial Phase 2 study, sponsored by Indiana University.
NCT00811434 is a Phase 2 study that was terminated before completion, run by Indiana University. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00811434, a Phase 2 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
Primary Outcome
failure of one cognitive function test indicates presence of MHE
Interventions
- DRUG placebo
- DRUG Lactulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
Why NCT00811434 stopped before completion
NCT00811434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00811434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00811434 about?
NCT00811434 is a clinical study titled "Study of Lactulose in Children With Chronic Liver Disease". Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded place...
What is the current status of trial NCT00811434?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2009-01. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00811434?
The interventions under investigation include: placebo (DRUG), Lactulose (DRUG).
Who is sponsoring clinical trial NCT00811434?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00811434's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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