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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 is a Phase 2 study that was terminated before completion, run by Indiana University. The registered enrollment target is 16 participants.
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.
Interventions
- DRUG placebo
- DRUG Lactulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00811434
The ClinicalTrials.gov registry entry for NCT00811434 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00811434 reports 0 study locations.
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.
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